434-2020 (COMIECO-XCIII) dated December 10, 2020 and its Annex "Central American Technical Regulation RTCA 65.05.67:18 AGRICULTURAL INPUTS. TECHNICAL GRADE ACTIVE INGREDIENT, FORMULATED CHEMICAL PESTICIDES, RELATED SUBSTANCES, ADJUVANTS, AND PHYSICAL VEHICLES FOR AGRICULTURAL USE. REQUIREMENTS FOR THE PREPARATION OF LABELS AND PAMPHLETS" be published, as transcribed below:
"RESOLUTION No. 434-2020 (COMIECO-XCIII) THE COUNCIL OF MINISTERS OF ECONOMIC INTEGRATION
Pursuant to articles 38, 39, and 55 of the Protocol to the General Treaty of Central American Economic Integration (Guatemala Protocol), amended by the Amendment of February 27, 2002, the Council of Ministers of Economic Integration (COMIECO) has under its purview matters of Central American Economic Integration and, as such, is responsible for approving the administrative acts applicable in the States Parties of the Economic Subsystem; Pursuant to articles 7 and 26 of the Guatemala Protocol, the States Parties have agreed to establish a process of regional harmonization of technical regulations; COMIECO, through Resolution No. 401-2018 (COMIECO-LXXXIII), of June 28, 2018, approved the Central American Technical Regulation RTCA 65.05.67:18 Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Adjuvants, and Physical Vehicles for Agricultural Use. Requirements for the Preparation of Labels and Pamphlets, and the bodies of Economic Integration made the decision to review and amend the referenced RTCA, and therefore have submitted it for the consideration of this forum; COMIECO may meet virtually through the videoconference system, in which case it is the responsibility of the Secretariat of Central American Economic Integration (SIECA) to collect the signature of each of the Ministers or Vice Ministers, as applicable, in their respective country,
Based on articles 1, 3, 5, 7, 15, 26, 36, 37, 38, 39, 46, 52, and 55 of the Guatemala Protocol; and 19, 20 Bis, 32, and 32 Bis of the Regulation of Organization and Functioning of the Councils: of Ministers of Economic Integration, Intersectoral of Ministers of Economic Integration, and Sectoral of Ministers of Economic Integration,
1. To amend, by complete substitution, the Central American Technical Regulation RTCA 65.05.67:18 Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Adjuvants, and Physical Vehicles for Agricultural Use. Requirements for the Preparation of Labels and Pamphlets, in the form appearing in the Annex to the present Resolution and which forms an integral part thereof.
2. To repeal Resolution No. 401-2018 (COMIECO-LXXXIII), of June 28, 2018, and Resolution No. 424-2020 (COMIECO-XCI), of June 23, 2020.
3. The present Resolution shall enter into force on August 10, 2021, and shall be published by the States Parties.
Central America, December 10, 2020 The undersigned Secretary General of the Secretariat of Central American Economic Integration (SIECA) CERTIFIES: That the two (2) photocopies preceding this sheet of bond paper, printed only on their front side, as well as one (1) attached annex, printed only on its front side, all initialed and stamped with the seal of SIECA, faithfully reproduce Resolution No. 434-2020 (COMIECO-XCIII), adopted by the Council of Ministers of Economic Integration, on December ten, two thousand twenty, through the videoconference system, from whose originals they were reproduced. And to remit to the States Parties for their corresponding publication, I issue this certified copy in Guatemala City, Guatemala, on February first, two thousand twenty-one.----------- --------------------------------------------------------------------------------------- Melvin Redondo Secretary General CENTRAL AMERICAN TECHNICAL REGULATION RTCA 65.05.67:18 ICS 65.100 1st Revision AGRICULTURAL INPUTS. TECHNICAL GRADE ACTIVE INGREDIENT, FORMULATED CHEMICAL PESTICIDES, RELATED SUBSTANCES, ADJUVANTS, AND PHYSICAL VEHICLES FOR AGRICULTURAL USE. REQUIREMENTS FOR THE PREPARATION OF LABELS AND PAMPHLETS.
CORRESPONDENCE: this technical regulation has no correspondence with any international standard. Edited by:
? Ministry of Economy of Guatemala. MINECO ? Salvadoran Technical Regulation Body. OSARTEC ? Secretariat of Economic Development of Honduras. SDE ? Ministry of Development, Industry, and Commerce of Nicaragua. MIFIC ? Ministry of Economy, Industry, and Commerce of Costa Rica. MEIC ? Ministry of Commerce and Industries of Panama. MICI REPORT The respective Technical Committees for Standardization and Technical Regulation, through the standardization and technical regulation bodies of the countries of the Central American region and their successors, are the bodies responsible for conducting the study or adoption of technical regulations, and are composed of representatives from the academic, consumer, private enterprise, and government sectors.
This document was approved as Central American Technical Regulation, RTCA 65.05.67:18 AGRICULTURAL INPUTS. TECHNICAL GRADE ACTIVE INGREDIENT, FORMULATED CHEMICAL PESTICIDES, RELATED SUBSTANCES, ADJUVANTS, AND PHYSICAL VEHICLES FOR AGRICULTURAL USE. REQUIREMENTS FOR THE PREPARATION OF LABELS AND PAMPHLETS, FIRST REVISION, by the Subgroup on Agricultural and Livestock Inputs. The officialization of this technical regulation entails ratification by the Council of Ministers of Central American Economic Integration (COMIECO).
PARTICIPATING MEMBERS For Guatemala Ministry of Agriculture, Livestock, and Food For El Salvador Ministry of Agriculture and Livestock For Honduras Secretariat of Agriculture and Livestock For Nicaragua National Commission for the Registration and Control of Toxic Substances For Costa Rica Ministry of Agriculture and Livestock For Panama Ministry of Agricultural Development 1. OBJECT To establish the information that must be contained on the label and in the pamphlet of formulated chemical pesticides, related substances, adjuvants, and physical vehicles for agricultural use, as well as the identification of the technical grade active ingredient, as applicable.
2. SCOPE OF APPLICATION Applies to the labels and pamphlets of formulated chemical pesticides (synthetic and of inorganic origin), related substances, adjuvants, and physical vehicles that are manufactured, packaged, repackaged, imported, distributed, and marketed in the States Parties, as well as the identification of registered technical grade active ingredients.
3. DEFINITIONS 3.1 Pesticide class: determines the biological action of the pesticide, for example: insecticide, fungicide, herbicide, and nematicide, among others.
3.2 Adjuvant: chemical substance that contributes to, assists, or helps to achieve a better biological action of the formulated chemical pesticide (sticker, dispersant, humectant, penetrant, and pH regulator, among others), when correctly mixed with it.
3.3 Multiple package: product with a particular presentation, where in the same packaging unit or container there are two or more active ingredients in formulations physically separated from each other. The formulation type of the active ingredients that compose the multiple package may be the same or different.
3.4 Container or package: receptacle that is in direct contact with the product labeled in accordance with the present regulation, to preserve it, identify it, and facilitate its transport.
3.5 Stamped: engraved with indelible ink on the container or on the already prepared label.
3.6 Label: written, printed, or graphic material that is on the surface of the container, adhered (glued) or stamped to the container of the product covered by this regulation, which identifies and describes the product contained in the container.
3.7 Manufacturer: natural or legal person, individual or collective, dedicated to the synthesis or production of technical grade active ingredient.
3.8 Formulation: preparation of formulated chemical pesticides, related substances, and adjuvants that may contain one or more active ingredients and formulation auxiliaries in a form suitable for use.
3.9 Formulator: natural or legal person, individual or collective, dedicated to the formulation of formulated chemical pesticides and related substances.
3.10 Importer: natural or legal person, individual or collective, that imports formulated chemical pesticides, technical grade active ingredients, adjuvants, physical vehicles, and related substances for agricultural use that comply with the provisions of the present regulation.
3.11 Printed: material that has been obtained through the art of printing or a related system.
3.12 Technical grade active ingredient: that which contains the chemical elements and their natural or manufactured compounds, including impurities and related compounds that may inevitably result from the manufacturing process. The technical grade active ingredient can be found under two designations: technical material (TC) and technical concentrate (TK). Technical material (TC) normally has a high concentration of active ingredient and may have essential additives such as stabilizers, but does not have diluents or solvents. Technical concentrate (TK) normally contains a lower concentration of active ingredient, may have essential additives such as stabilizers, as well as diluents or solvents.
3.13 Dermal intoxication: clinical picture or state in which adverse effects occur as a result of absorption through the skin of a formulated synthetic pesticide, technical grade active ingredient, adjuvants, and related substances.
3.14 Oral intoxication: clinical picture or state in which toxic effects are produced by a formulated synthetic pesticide, technical grade active ingredient, adjuvants, and related substances when absorbed by ingestion.
3.15 Inhalation intoxication: clinical picture or state in which the manifestations of toxic effects are caused by a formulated synthetic pesticide, technical grade active ingredient, adjuvants, and related substances absorbed through the respiratory tract.
3.16 Brand (product name): any sign or combination of signs that distinguishes the goods of one person (individual or collective, natural or legal) from those of another, as these are considered sufficiently distinctive or capable of identifying the goods to which they are applied compared to those of the same species or class.
3.17 Mechanism of action: manner in which the pesticide acts directly on the physiological processes of pests.
3.18 Mode of action: manner in which the pesticide must come into contact to perform its action (contact and ingestion, among others).
3.19 Trade name: denominative or mixed sign that identifies and distinguishes a company or a specific commercial establishment.
3.20 Generic or common name: common name of the active ingredient approved by ISO or proposed to ISO, in the English language.
3.21 Chemical name: name of the active ingredient approved by IUPAC.
3.22 Pamphlet or instruction leaflet: printed material that accompanies each commercial presentation of the formulated chemical pesticide or related substance, which complies with the information and requirements established in this regulation.
3.23 Pictogram: a graphic composition containing a symbol, as well as other graphic elements, such as a border, a motif, or a background color, and which serves to communicate specific information. For purposes of applying this Regulation, they are those established in Annex B (Table B.2) and in Annex C.
3.24 Restricted-use and sale pesticide: pesticide that, due to its risk level, its sale and use is conditioned upon special handling practices specified by the National Competent Authority (ANC).
3.25 Formulated chemical pesticide: commercial product that has been prepared from one or more technical grade active ingredients plus the other components of the formulation, following established quality standards, for its packaging, packing, and sale.
3.26 Inorganic pesticide: these are products extracted from natural sources.
3.27 Related substances: substances intended for use as defoliants, desiccants, sun protectants, pheromones, pre-sowing seed protectants against the action of chemical substances, oils, repellents, agents for reducing fruit density, or agents for preventing premature fruit drop, and substances applied to crops before or after harvest to protect the product against deterioration during storage and transport (waxes, soaps, silver citrate, and hydrogen peroxide, among others). The term also includes hormones, growth regulators, ripening regulators, and flowering induction regulators that are produced naturally in plants and that have been able to be reproduced synthetically, among others.
3.28 Pesticide chemical group or family: chemical group to which a product belongs, such as organophosphates, carbamates, pyrethroids, and sulfonylureas, among others; using as a reference what is established by recognized international organizations.
3.29 Registration holder: natural or legal person, individual or collective, owner of the registration of a formulated chemical pesticide, technical grade active ingredient, adjuvant, or related substance before the ANC.
3.30 Physical vehicle: inert medium that provides the adequate contact surface or fixes some pesticide (technical grade active ingredient or formulation) or related substance, such as bags, traps, sheets, and sticks with pesticides or related substances. Does not include formulation auxiliaries (inerts) used in the formulation of pesticides.
4. ABBREVIATIONS (ACRONYMS) 4.1 ANC: National Competent Authority.
4.2 FAO: Food and Agriculture Organization of the United Nations.
4.3 GHS: Globally Harmonized System.
4.4 IAGT: Technical Grade Active Ingredient.
4.5 ISO: International Organization for Standardization.
4.6 IUPAC: International Union of Pure and Applied Chemistry.
4.7 SI: International System of Measurement.
5. GENERAL PROVISIONS 5.1 Basic principles 5.1.1 Labels must be placed so that they do not separate from the product container or package under normal conditions of use.
5.1.2 Labels must be of such quality that they withstand the action of atmospheric agents under normal conditions of use, transport, and storage.
5.1.3 The language must be clear, brief, simple, and free of ideas that tend towards exaggeration of the qualities or real capabilities of the product. Words must be in common use, avoiding technicalities that confuse the user, and employing words that accurately define the idea.
5.1.4 Labels and pamphlets must not use words, illustrations, graphics, or other graphic representations that mislead or confuse the user in any way.
5.1.5 The use of stickers, corrections, or alterations on the label or container is not permitted.
This numeral is excepted for matters relating to price and barcode, without affecting the content of the label.
5.1.6 When a State Party has regulations on restricted-use formulated chemical pesticides, the product label marketed in that State must indicate the following legend: "RESTRICTED-USE PRODUCT", at the top of the central body and centered, in uppercase and bold letters, of the same size as the signal words, proportional to the size of the label, in accordance with the provisions of numeral 5.3.1.
5.1.7 The texts and legends on the label must be drafted in Spanish or Castilian, with the exception of the chemical name according to IUPAC, the common name according to ISO, and the acronyms that qualify the formulation in question, according to Annex A.
5.1.8 The use of the company's logotype (trademark) must not interfere with the mandatory information on the label or the pamphlet, and its size must not be larger than 4% of the total area of the label or the pamphlet (3.19) and must be located on the front face, duly centered and located above the brand (name of the product).
5.1.9 On the label and the pamphlet, the use of indications such as: "non-toxic", "harmless", with or without a qualifying phrase such as: "if used according to instructions" or any other analogous indication, is not permitted; nor is the use of extensive terms such as: "etc.", "and others", "widely", "the most diverse", "certain", "almost all", "the majority", or any other analogous indication permitted.
5.1.10 The graphic representations, figures, pictograms, or designs required on the label must comply with the provisions of this regulation, as defined in numerals 5.1.4 and 5.1.8. Do not use drawings that confuse or induce misuse of the product.
5.1.11 Labels and pamphlets shall be drafted with black letters on a white background, and no other color shall appear on them, except those identifying the logotypes of the manufacturer, formulator, or distributor, brands, figures, and the band corresponding to the toxicological category.
NOTE 1. Exempted from this rule are those labels lithographed or printed on containers or packages made of material of a color other than white for photosensitive pesticides.
5.1.12 Containers or packages of formulated chemical pesticides must have a pamphlet attached.
5.1.13 On the product label and pamphlet, the International System of Units (SI), or the units recognized by it, shall be used to cite units of length, area, volume, and mass.
5.1.14 The indications under the title "FIRST AID" must include an explanation of the applicable measures for exposure via oral, inhalation, or contact with skin and eyes, which must be:
- IN CASE OF INGESTION: do not induce vomiting. Immediately take the patient to the nearest doctor or health center. Take the available information on the product (label or pamphlet).
- IN CASE OF SKIN CONTACT: remove contaminated clothing, immediately wash the affected area of the body with plenty of soap and water for 15 to 20 minutes. Take the patient to the nearest doctor or health center. Take the available information on the product (label or pamphlet).
- IN CASE OF INHALATION: move the person to a ventilated area. Immediately take the patient to the nearest doctor or health center. Take the available information on the product (label or pamphlet).
- IN CASE OF EYE CONTACT: wash them with water for 15 to 20 minutes.
Immediately take the patient to the nearest doctor or health center. Take the available information on the product (label or pamphlet).
NOTE 1. These indications may be expanded, depending on the toxicity and certain physical and chemical characteristics of the substances, as well as the formulator's recommendations.
5.1.15 The product's highest toxicity value according to its oral or dermal LD50 must be used for the toxicological classification established in Annex B of this regulation.
5.2 Label dimensions The label size must be in accordance with the following proportions:
5.2.1 On containers or packages with a capacity up to 1L or 1kg, the label must cover at least 75% of the total surface thereof, excluding the top, bottom, and side of the container or package.
5.2.2 On containers or packages with a capacity greater than 1L or 1kg up to 3.785L or 5kg, the label must cover at least 40% of the total surface thereof, excluding the top, bottom, and side of the container or package.
5.2.3 On containers or packages larger than 3.785 L or 5 kg up to 18 L or 25 kg, the label must cover at least 25% of the total surface thereof, excluding the top and bottom of the container or package.
5.2.4 On containers or packages with a capacity greater than 18L or 25kg, the label size must cover at least 10% of the total surface thereof, excluding the top and bottom of the container or package.
5.3 Font size, printing style, and pictograms for labels and pamphlets.
5.3.1 Font size The warning legends required by this regulation must be in uppercase, in bold, and in proportion to the label size, with a size not less than 1.5mm (6 points) and all other texts not less than 1mm (4 points).
In the case of containers less than or equal to 100 ml or 100 gr, the font size of the legend and the rest of the text must not be less than 1mm (4 points).
5.3.2 Printing styles 5.3.2.1 The printing on the label and pamphlet must be in the same direction and must never overlap.
5.3.2.2 Condensed printing must never be used.
5.3.2.3 Italic and bold printing must only be used for scientific names.
5.3.2.4 The Verdana style!important must be used for the information contained on the label.
5.3.3 Size and placement of pictograms 5.3.3.1 The pictograms required by this regulation must be of such dimensions as to allow the user to identify and understand the message. The pictogram size must be proportional to that of the label, and the minimum permitted is 7mm x 7mm.
5.3.3.2 The pictograms shall be placed to the right of the corresponding legends.
5.3.3.3 The pictograms must be printed on a white background with a black figure.
5.4 Label information 5.4.1 Brand (product name), followed by the concentration of the active ingredient expressed as mass/mass percentage (% m/m) for solids and mass/volume percentage (% m/v) for liquids, without placing the percentage symbol, followed by the acronyms of the pesticide formulation. (CENTERED, UPPERCASE, AND BOLD).
5.4.2 The class, groupe, or chemical family of the pesticide, related substances, adjuvants, and labels for physical vehicles containing pesticides, must follow the following indications, as applicable (CENTERED, UPPERCASE, AND BOLD).
5.4.2.1 For mixtures of pesticides, related substances, adjuvants, and physical vehicles, the families or chemical groups or active ingredients shall be declared individually, as applicable, as follows:
- a)Mixtures of classes, shall be separated by commas (CENTERED, UPPERCASE, AND BOLD).
- b)Mixtures of chemical group or family, shall be separated by commas (CENTERED, UPPERCASE, AND BOLD).
- c)Mixtures of chemical group or family and class, shall be separated by a hyphen (CENTERED, UPPERCASE, AND BOLD).
- d)The names of the active ingredients in a mixture are separated from each other by commas (CENTERED, UPPERCASE, AND BOLD).
5.4.3 The common name of the active ingredient approved by ISO or proposed to ISO, in English. (CENTERED, UPPERCASE, AND BOLD).
5.4.4 Under the title "Chemical Composition" (in bold and aligned to the left) the following must be indicated:
- a)The chemical name of the active ingredient (according to IUPAC) and its concentration, which must be expressed in mass/mass percentage (% m/m) if solid and mass/volume percentage (% m/v) if liquid. The abbreviations for mass/mass percentage (% m/m), mass/volume percentage (% m/v) must be placed above the digits indicating said percentage.
For the case of pesticides, related substances, and adjuvants for which the name approved by IUPAC is not available, the one proposed by the manufacturer or formulator of the product shall be used.
- b)The concentration or mass/volume percentage (% m/v) if it is a liquid. The abbreviations for mass/mass percentage (% m/m) or mass/volume percentage (% m/v) must be placed at the top of the digits indicating said percentage.
- c)The common name of the hydrocarbon-based solvent, when the product contains this type of solvent.
NOTE 1. The percentages mentioned above must carry two (2) decimal places, which must be separated by a comma according to the SI (aligned to the right side of the chemical composition). The sum of the percentages must not be indicated.
5.4.5 The product density value must be declared when it is liquid and the temperature in degrees Celsius at which it was determined. The word DENSITY: CENTERED, UPPERCASE, AND BOLD.
5.4.6 For multiple packages, the formulation of each product must be indicated, using separate boxes, as well as the common name of the active ingredient of each product.
5.4.7 The grams of active ingredient per kilogram or liter of commercial product must be indicated after the title "Contains:" (in bold letters and aligned to the left).
5.4.8 The quantity of product contained in the container/package must be declared, expressed in units according to the SI or accepted by it, for which the phrase "Net Content" (in bold letters and aligned to the left) shall be used.
5.4.9 In the central part of the label and below the net content and centered, the word and figure corresponding to the toxicological category, established in Annex B of this regulation, shall be placed.
5.4.10 For the product that requires a pamphlet, the label must have the following legend: "¡ALTO! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT A PROFESSIONAL IN AGRONOMIC SCIENCES" CENTERED, IN UPPERCASE AND BOLD LETTERS).
NOTE 1. This shall apply to one, two, and three-body label formats (see numeral 7).
5.4.11 The adjuvant label must contain the following legend: "¡ALTO! LEA LA ETIQUETA Y EL PANFLETO ANTES DE USAR EL PRODUCTO, CONSULTE AL PROFESIONAL EN CIENCIAS AGRONÓMICAS". (CENTERED, IN UPPERCASE AND BOLD).
NOTE 1. It will apply to one-, two-, and three-body label formats (see numeral 9).
5.4.12 The label of formulated chemical pesticides, related substances, and physical carriers for agricultural use must contain the following legends (CENTERED, IN UPPERCASE AND BOLD): "¡ALTO! LEA LA ETIQUETA Y EL PANFLETO ANTES DE USAR EL PRODUCTO, CONSULTE AL PROFESIONAL EN CIENCIAS AGRONÓMICAS". "CUMPLA CON LAS RECOMENDACIONES DADAS EN LA ETIQUETA Y EL PANFLETO". "PROTEJA EL AMBIENTE CON BUENAS PRÁCTICAS AGRÍCOLAS".
Note 1. The following legend "¡ALTO! LEA LA ETIQUETA Y EL PANFLETO ANTES DE USAR EL PRODUCTO, CONSULTE AL PROFESIONAL EN CIENCIAS AGRONÓMICAS" shall not be included on the right-hand body of the three-body label, for formulated chemical pesticides.
5.4.13 For formulated chemical pesticides, the label must carry the following legends, as applicable, under the heading "PROTECCIÓN AL AMBIENTE", (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD):
- TÓXICO PARA EL GANADO and its pictogram.
- TÓXICO PARA AVES and its pictogram.
- TÓXICO PARA ABEJAS and its pictogram.
- TÓXICO PARA PECES O CRUSTÁCEOS and its pictogram.
- MANEJO DE ENVASES and the triple-rinse pictogram, when applicable according to the container type, material, and formulation.
- NO CONTAMINE RÍOS, LAGOS Y ESTANQUES CON ESTE PRODUCTO, CON ENVASES O EMPAQUES VACÍOS (CENTERED, IN UPPERCASE AND BOLD).
5.4.14 Warning legends in case of poisoning and for the antidote Products labeled in accordance with this regulation must include warning legends in case of poisoning and their antidote when one exists, in accordance with the following specifications:
5.4.14.1 The following legend must be indicated in (UPPERCASE, BOLD AND CENTERED): EN CASO DE INTOXICACIÓN TRASLADE EL PACIENTE AL MÉDICO O CENTRO DE SALUD MÁS CERCANO Y ENTREGUE LA ETIQUETA Y EL PANFLETO.
5.4.14.2 Following the legend ANTÍDOTO (UPPERCASE, IN BOLD AND CENTERED), the name of the antidote must be indicated if one exists; if none exists, include the legend "NO TIENE". In the case of multiple packaging, if an antidote exists for one or more of the active ingredients comprising it, they shall be reported indicating to which active ingredient each corresponds.
5.4.14.3 Under the heading SÍNTOMAS DE INTOXICACIÓN (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), the characteristic symptoms of poisoning caused by the pesticide must be indicated.
5.4.15 Precaution and use warning legends.
Under the heading PRECAUCIONES Y ADVERTENCIAS DE USO: the following legends must be presented (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), along with their respective pictogram (Anexo C) aligned to the corresponding phrase on the right side:
- NO ALMACENAR ESTE PRODUCTO EN CASAS DE HABITACIÓN. MANTÉNGASE BAJO LLAVE FUERA DEL ALCANCE DE LOS NIÑOS, PERSONAS CON DISCAPACIDAD MENTAL, ANIMALES, ALIMENTOS Y MEDICAMENTOS.
- UTILICE EL SIGUIENTE EQUIPO DE PROTECCIÓN AL MANIPULAR EL PRODUCTO, DURANTE LA PREPARACIÓN DE LA MEZCLA, CARGA Y APLICACIÓN: GUANTES Y BOTAS DE HULE, MASCARILLA, SOMBRERO, PROTECTOR DE OJOS, PANTALÓN Y CAMISA DE MANGA LARGA Y DELANTAL DE MATERIAL IMPERMEABLE (should additional or specific equipment be required, the registrant must indicate it, according to the product's characteristics).
- NO COMER, FUMAR O BEBER DURANTE LA MANIPULACIÓN DE ESTE PRODUCTO. BÁÑESE DESPUÉS DE TRABAJAR Y PÓNGASE ROPA LIMPIA.
5.4.16 Other legends on the label 5.4.16.1 First aid legend Under the legend "PRIMEROS AUXILIOS" (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD). According to numeral 5.1.14, an explanation of the applicable measures must be added for EN CASO DE INGESTIÓN: EN CASO DE CONTACTO CON LA PIEL: EN CASO DE INHALACIÓN: and EN CASO DE CONTACTO CON LOS OJOS: in that order.
5.4.16.2 Medical recommendation legends a) The legend "NUNCA DE A BEBER NI INDUZCA EL VÓMITO A PERSONAS EN ESTADO DE INCONSCIENCIA" must be included (CENTERED, UPPERCASE AND BOLD).
- b)Under the legend "TRATAMIENTO MÉDICO" (LEFT-ALIGNED, IN BOLD AND UPPERCASE), the general or specific procedure must be indicated.
5.4.17 Labels regulated by this regulation must also contain the following information:
5.4.17.1 Name and address of the formulator or manufacturer: as the case may be (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD). The name and address, telephone number, and email must be identified. This information must be presented using the legend "FORMULADOR O FABRICANTE", as the case may be.
5.4.17.2 Country and registration number: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD).
To fulfill this requirement, the heading "País y número de registro" must be used and it shall be located at the bottom of the other legends.
5.4.17.3 Batch number and product expiry 5.4.17.3.1 The batch number must be printed or stamped on the label or on the container, with the exception of the cap, and shall be preceded by the phrase "NÚMERO DE LOTE:" (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD).
5.4.17.3.2 The formulation date for formulated products or the manufacturing date for IAGT, as the case may be, must be printed or stamped on the label or on the container, with the exception of the cap, in a visible place, indicating month and year. Furthermore, it shall be preceded by the phrase "FECHA DE FORMULACIÓN O FABRICACIÓN: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD).
5.4.17.3.3 The expiry date must be printed or stamped on the label or on the container, with the exception of the cap, in a visible place, indicating month and year. Furthermore, it shall be preceded by the phrase "FECHA DE VENCIMIENTO:" (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD).
5.4.18 Warranty notice This heading must be written in uppercase letters, in bold, left-aligned, and with a colon at the end of the phrase: "AVISO DE GARANTÍA:" the conditions under which the registration holder or the manufacturer or the formulator or the distributor offers the pesticide warranty, in compliance with the national legislation in force in each of the State Parties, must be described. This must be included on the label and in the pamphlet. Single-body labels are exempted, in which case it will only be mandatory in the pamphlet.
6. CLASIFICACIÓN TOXICOLÓGICA, COLOR DE LA BANDA, PICTOGRAMA Y PALABRAS DE ADVERTENCIA 6.1 The toxicological classification of products shall be defined as established in Anexo B of this regulation.
The ANC will evaluate, from the registration dossier, the data corresponding to the Oral Acute Median Lethal Dose (DL50), the Dermal Acute Median Lethal Dose (DL50), and the Acute Median Lethal Concentration by Inhalation (CL50), according to the route and types of exposure.
6.2 Every label shall have a colored band in accordance with the toxicological classification of Anexo B. Said band shall be placed on the lower part of the label (across its full width) and must occupy 15% of the total height of the label. The distinctive colors of all categories shall not have color variations; which is defined by means of PMS (Pantone Matching System), characteristic as established in Anexo B of this regulation.
6.3 Each toxicological category shall have a pictogram and warning word, established in Anexo B of this regulation.
6.4 The pictogram (symbol) and "warning" word, according to their toxicological classification and category, must be located in the central part of the label and centered.
7. FORMATOS DE ETIQUETAS DE 1, 2 Y 3 CUERPOS PARA PLAGUICIDAS QUÍMICOS FORMULADOS1 1These formats do not apply to technical-grade active ingredients.
7.1 One-body label The one-body label applies to products whose container or package has a capacity less than or equal to half a liter or half a kilogram, and its distribution is as follows:
- a)Legend: as established in numeral 5.4.10.
- b)Company logo (empresa): registration holder, formulator, or distributor, as defined in numeral 5.1.8.
- c)Brand (product name): followed by the concentration of the active ingredient, expressed in numbers and the abbreviations of the pesticide formulation, as defined in numeral 3.16.
- d)Class, group, or chemical family of the pesticide: as defined in numerals 3.1, 3.28 and 5.4.2.
- e)For mixtures of pesticides: comply with numeral 5.4.2.1.
- f)Common name of the active ingredient: as defined in numerals 3.20 and 5.4.3.
- g)Chemical composition: must comply with numeral 5.4.4 h) Contains: amount of active ingredient as defined in numeral 5.4.7.
- i)Density: (for liquids) as defined in numeral 5.4.5.
- j)Net content: as defined in numeral 5.4.8.
- k)The pictogram (symbol) and "warning" word: according to its toxicological category, in the central part of the label, below the net content, as defined in numeral 6 and Table B.2 of Anexo B of this regulation.
- l)Legend for case of poisoning: as defined in numeral 5.4.14.1.
- m)Legend for antidote: as defined in numeral 5.4.14.2.
- n)Formulator: as defined in numeral 5.4.17.1.
- o)Country and registration number: as defined in numeral 5.4.17.2.
- p)Batch number: as defined in numeral 5.4.17.3.1.
- q)Formulation date: as defined in numeral 5.4.17.3.2.
- r)Product expiry date: as defined in numeral 5.4.17.3.3.
- s)Colored band according to the product's toxicological classification and category: as defined in numeral 6 and Table B.3 of Anexo B of this regulation.
NOTES:
1. The concentration must be expressed as a mass/mass percentage (%m/m) for solids and as a mass/volume percentage (%m/v) for liquids, as defined in the note of numeral 5.4.4, literals a and b.
2. In the event that more than one active substance is chemically mixed, the percentages shall be added to establish the total concentration.
3. For multi-pack packaging, the concentration and the formulation abbreviations of each of the components must be separated by slashes.
4. For 250ml, 250g containers or smaller, if the required information cannot be placed in the established order, it must be situated within the space of the label body.
7.2 Two-body label The two-body label applies to products whose container or package has a capacity greater than half a liter or half a kilogram, and its distribution is as follows:
7.2.1 All bodies Along the length of each of the two bodies of the label, the following requirements must be added:
- a)Legend: in accordance with the provisions of 5.4.10.
- b)Colored band according to the product's toxicological classification and category: as defined in numeral 6 and Table B.3 of Anexo B of this regulation.
7.2.2 Front body a) Company logo (empresa): registration holder, formulator, or distributor, as defined in numeral 5.1.8.
- b)Brand (product name): followed by the concentration of the active ingredient, expressed in numbers and the abbreviations of the pesticide formulation, as defined in numeral 3.16.
- c)Class, group, or chemical family of the pesticide: as defined in numerals 3.1, 3.28 and 5.4.2.
- d)For mixtures of pesticides: comply with numeral 5.4.2.1.
- e)Common name of the active ingredient: as defined in numeral 3.20 and 5.4.3.
- f)Chemical composition: must comply with numeral 5.4.4.
- g)Contains: amount of active ingredient, as defined in numeral 5.4.7 h) Density (for liquids): as defined in numeral 5.4.5.
- i)Net content: as defined in numeral 5.4.8.
- j)The pictogram (symbol) and "warning" word: according to its toxicological classification and category, as defined in numeral 6 and Table B.2 of Anexo B of this regulation.
- k)Legend for case of poisoning: as defined in numeral 5.4.14.1.
- l)Legend for antidote: as defined in numeral 5.4.14.2.
- m)Formulator: as defined in numeral 5.4.17.1.
- n)Precautions and use warnings: as defined in numeral 5.4.15.
- o)Symptoms of poisoning: as defined in numeral 5.4.14.3.
- p)First aid legend, as defined in numeral 5.4.16.1/5.1.14.
- q)Medical recommendation legends: as defined in numeral 5.4.16.2.
- r)Colored band according to the product's toxicological classification and category: as defined in numeral 6 and Table B.3 of Anexo B of this regulation.
NOTES:
1. The concentration must be expressed as a mass/mass percentage (% m/m) for solids and a mass/volume percentage (%m/v) for liquids, as defined in the note of numeral 5.4.4, literals a and b.
2. In the event that more than one active substance is chemically mixed, the percentages shall be added to establish the total concentration.
3. For multi-pack packaging, the concentration and the formulation abbreviations of each of the components must be separated by slashes.
7.2.3 Back body a) Environmental protection legend: as defined in numerals 5.4.12 and 5.4.13.
- b)Warranty notice: as defined in numeral 5.4.18.
- c)Country and registration number: as defined in numeral 5.4.17.2.
- d)Batch number: as defined in numeral 5.4.17.3.1.
- e)Formulation date: as defined in numeral 5.4.17.3.2.
- f)Product expiry date: as defined in numeral 5.4.17.3.3 g) Colored band according to the product's toxicological classification and category: as defined in numeral 6 and Table B.3 of Anexo B of this regulation.
7.3 Three-body label The three-body label applies to products whose container or package has a capacity greater than half a liter or half a kilogram, and its distribution is as follows:
7.3.1 All bodies Along the length of the three bodies of the label, the following requirements must be added:
- a)Legend: in accordance with the provisions of 5.4.11.
- b)Colored band according to the product's toxicological classification and category: as defined in numeral 6 and Table B.3 of Anexo B of this regulation.
7.3.2 Left body a) Precaution and use warning legends: as defined in numeral 5.4.15.
- b)Legend: the following legend must be indicated in (UPPERCASE, BOLD AND CENTERED): "EN CASO DE INTOXICACIÓN TRASLADE EL PACIENTE AL MÉDICO O CENTRO DE SALUD MÁS CERCANO Y ENTREGUE LA ETIQUETA Y EL PANFLETO", as defined in numeral 5.4.14.1.
- c)Symptoms of poisoning: as defined in numeral 5.4.14.3.
- d)First aid: as defined in numeral 5.4.16.1.
- e)Medical recommendation legends: as defined in numeral 5.4.16.2.
7.3.3 Central body a) Company logo (empresa): registration holder, formulator, or distributor, as defined in numeral 5.1.8.
- b)Brand (product name): followed by the concentration of the active ingredient, expressed in numbers and the abbreviations of the pesticide formulation, as defined in numeral 3.16.
- c)Class, group, or chemical family of the pesticide: as defined in numerals 3.1, 3.28 and 5.4.2.
- d)For mixtures of pesticides: comply with numeral 5.4.2.1.
- e)Common name of the active ingredient: as defined in numeral 3. 20.
- f)Chemical composition: must comply with numeral 5.4.4.
- g)Contains: amount of active ingredient as defined in numeral 5.4.7.
- h)Density (for liquids): as defined in numeral 5.4.5.
- i)Net content: as defined in numeral 5.4.8.
- j)The pictogram (symbol) and "warning" word: according to its toxicological classification and category as defined in numeral 6 and Table B.2 of Anexo B of this regulation.
- k)Antidote: as defined in numeral 5.4.14.2.
- l)Formulator: as defined in numeral 5.4.17.1.
NOTES:
1. The concentration must be expressed as a mass/mass percentage (%m/m) for solids and a mass/volume percentage (%m/v) for liquids, as defined in the note of numeral 5.4.4, literals a and b.
2. In the event that more than one active substance is chemically mixed, the percentages shall be added to establish the total concentration.
3. For multi-pack packaging, the concentration and the formulation abbreviations of each of the components must be separated by slashes.
7.3.4 Right body a) Environmental protection legend: as defined in numerals 5.4.12 and 5.4.13.
- b)Warranty notice: as defined in numeral 5.4.19.
- c)Country and registration number: as defined in numeral 5.4.17.2.
- d)Batch number: as defined in numeral 5.4.17.3.1.
- e)Formulation date: as defined in numeral 5.4.17.3.2.
- f)Product expiry date: as defined in numeral 5.4.17.3.3.
8. IDENTIFICACIÓN DEL INGREDIENTE ACTIVO GRADO TÉCNICO PARA FORMULAR PRODUCTOS DE USO AGRÍCOLA 8.1 The label that the IAGT will display shall have the following information printed on it:
8.1.1 Manufacturer company logo (empresa): as defined in numeral 5.1.8.
8.1.2 Brand (product name) and concentration of the active ingredient: as defined in numerals 3.12 and 5.4.1.
8.1.3 Class, group, or chemical family of the pesticide: as defined in numerals 3.1 and 3.28.
8.1.4 Common name of the active ingredient: ISO as defined in numeral 3.20.
8.1.5 Chemical composition: of the product as defined in numeral 5.4.4.
8.1.6 Contains: grams of active ingredient per liter or kilogram of technical product, per numeral 5.4.7.
8.1.7 Net content: as defined in numeral 5.4.8.
8.1.8 The pictogram (symbol) and "warning" word: according to its toxicological classification and category (CENTERED, UPPERCASE AND BOLD), as defined in numeral 6 and Table B2 of Anexo B of this regulation.
8.1.9 Antidote and indications for medical treatment: as defined in numerals 5.4.14.2 and 5.4.16.2.
- Legends in uppercase and bold stating: "ESTE PRODUCTO PUEDE SER MORTAL SI SE INGIERE Y/O SE INHALA". "PUEDE OCASIONAR DAÑOS A LOS OJOS Y A LA PIEL POR EXPOSICIÓN" (Category 1 and 2). See Anexo C, Table B3.
8.1.10 Manufacturer's name, address, and country: as defined in numeral 5.4.17.1.
8.1.11 Single legend in (UPPERCASE, BOLD and CENTERED): "ANTES DE MANIPULAR, TRANSPORTAR Y ALMACENAR ESTE PRODUCTO LEA ESTA ETIQUETA".
8.1.12 For the case of technical-grade active ingredient pesticides, the label must carry the following legends, as applicable, under the heading "PROTECCIÓN AL AMBIENTE", (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD):
- TÓXICO PARA EL GANADO and its pictogram.
- TÓXICO PARA AVES and its pictogram.
- TÓXICO PARA ABEJAS and its pictogram.
- TÓXICO PARA PECES O CRUSTÁCEOS and its pictogram.
- NO CONTAMINE RÍOS, LAGOS Y ESTANQUES CON ESTE PRODUCTO, CON ENVASES O EMPAQUES VACÍOS (CENTERED, IN UPPERCASE AND BOLD).
- CUMPLA CON LAS RECOMENDACIONES DADAS EN LA ETIQUETA. PROTEJA EL AMBIENTE CON BUENAS PRÁCTICAS AGRÍCOLAS.
8.1.13 Legend ALMACENAMIENTO Y TRANSPORTE: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), indications about the storage and transport conditions of the product.
8.1.14 PELIGROS FÍSICOS Y QUÍMICOS: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), indicate flammability, corrosivity, among others, when applicable.
8.1.15 Warranty notice: the manufacturer must indicate that it guarantees the physicochemical conditions of the product as technical material, as defined in numeral 5.4.18 8.1.16 Importer's name: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), as defined in numeral 3.10.
8.1.17 Country and registration number: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), as defined in numeral 5.4.17.2.
8.1.18 The batch number: must be printed or stamped on the label or on the container, with the exception of the cap, and shall be preceded by the phrase NÚMERO DE LOTE: (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD).
8.1.19 Manufacturing date: as defined in numeral 5.4.17.3.2.
8.1.20 Expiry date: as defined in numeral 5.4.17.3.3.
8.1.21 Under the heading PRECAUCIONES Y ADVERTENCIAS DE USO: the following legends must be presented (IN UPPERCASE, LEFT-ALIGNED AND IN BOLD), along with their respective pictogram (Anexo C, literals A and C) aligned to the corresponding phrase on the right side:
- NO ALMACENAR ESTE PRODUCTO EN CASAS DE HABITACIÓN. MANTÉNGASE BAJO LLAVE FUERA DEL ALCANCE DE LOS NIÑOS, PERSONAS CON DISCAPACIDAD MENTAL, ANIMALES, ALIMENTOS Y MEDICAMENTOS.
- UTILICE EL SIGUIENTE EQUIPO DE PROTECCIÓN AL MANIPULAR EL PRODUCTO: GUANTES Y BOTAS DE HULE, MASCARILLA DE CARBÓN ACTIVADO, CASCO, PROTECTOR DE OJOS, PANTALÓN Y CAMISA DE MANGA LARGA Y DELANTAL DE MATERIAL IMPERMEABLE (should additional or specific equipment be required, the registrant must indicate it, according to the product's characteristics).
- NO COMER, FUMAR O BEBER DURANTE LA MANIPULACIÓN DE ESTE PRODUCTO. BÁÑESE DESPUÉS DE TRABAJAR Y PÓNGASE ROPA LIMPIA.
8.1.22 Symptoms of poisoning: as defined in numeral 5.4.14.3.
8.1.23 First aid: measures applicable in the case of poisoning, as defined in numerals 5.1.14 and 5.4.16.1.
8.1.24 Medical recommendation legends:
- a)The legend: "NUNCA DE A BEBER NI INDUZCA EL VÓMITO A PERSONAS EN ESTADO DE INCONSCIENCIA" must be included (CENTERED, UPPERCASE AND BOLD).
- b)Under the legend: "TRATAMIENTO MÉDICO" (LEFT-ALIGNED, IN BOLD AND UPPERCASE), the general or specific procedure must be indicated.
8.1.25 Every label shall have a colored band in accordance with the toxicological classification and category of Anexo B. Said band shall be placed on the lower part of the label (across its full width) and must occupy 15% of the total height of the label. The distinctive colors of all categories shall not have color variations; which is defined by means of PMS (Pantone Matching System), characteristic as established in Anexo B of this regulation.
8.2 The ANC must accept the identification of the technical-grade active ingredient, as established in numeral 8.1 of this regulation, or accept the identification of the label as established in the Globally Harmonized System.
9. ETIQUETAS DE LAS SUSTANCIAS AFINES, COADYUVANTES Y VEHÍCULOS FÍSICOS DE USO AGRÍCOLA Related substances, adjuvants, and physical carriers must carry a one-, two-, or three-body label with the following information:
9.1 One-body label The one-body label applies to products whose container or package has a capacity less than or equal to half a liter or half a kilogram, and the order is as follows:
9.1.1 Legend: "¡ALTO! LEA LA ETIQUETA Y EL PANFLETO ANTES DE USAR EL PRODUCTO, CONSULTE AL PROFESIONAL EN CIENCIAS AGRÓNOMICAS", (CENTERED, IN UPPERCASE AND BOLD), as defined in numeral 5.4.10.
9.1.2 Company logo (empresa): registration holder, formulator, or distributor (must be at the top and centered), as defined in numeral 5.1.8.
9.1.3 Brand (product name): concentration and formulation. Regarding formulation, only when applicable, as defined in numerals 3.16 and 5.4.1.
9.1.4 Class, group, or chemical family: as defined in numerals 3.1; 3.28; 5.4.2; 5.4.2.1. For adjuvants, indicate only the class.
9.1.5 Common name of the active ingredient(s) or the component(s): as defined in numerals 3.20 and 5.4.3. For adjuvants, indicate only the common name of the component.
9.1.6 Chemical composition: as defined in numeral 5.4.4, declare hydrocarbon-based solvents when they contain them.
9.1.7 Contains amount of active ingredient or components, as defined in numeral 5.4.7.
9.1.8 Density (for liquids): as defined in numeral 5.4.5.
9.1.9 Net content: as defined in numeral 5.4.8.
9.1.10 The pictogram (symbol) and "warning" word: according to its toxicological classification and category (CENTERED, UPPERCASE AND BOLD), as defined in numeral 6 and Table B2 of Anexo B of this regulation.
9.1.11 Antidote: as defined in numeral 5.4.14.2.
9.1.12 Legend "TRATAMIENTO MÉDICO": indicate the general or specific procedure, as defined in numeral 5.4.16.2, literal b.
9.1.13 "Warning" legend: "NO ALMACENAR ESTE PRODUCTO EN CASAS DE HABITACIÓN. MANTÉNGASE BAJO LLAVE FUERA DEL ALCANCE DE LOS NIÑOS, PERSONAS CON DISCAPACIDAD MENTAL, ANIMALES, ALIMENTOS Y MEDICAMENTOS" (CENTERED, UPPERCASE AND BOLD).
9.1.14 Formulator: as defined in numeral 5.4.17.1.
9.1.15 Country and registration number: as defined in numeral 5.4.17.2.
9.1.16 Batch number: as defined in numeral 5.4.17.3.1.
9.1.17 Formulation date: as defined in numeral 5.4.17.3.2.
9.1.18 Expiry date: as defined in numeral 5.4.17.3.3.
9.2 Two-body label 9.2.1 Front body The two-body label applies to products whose container or package has a capacity greater than or equal to half a liter or half a kilogram, and its order is as follows:
9.2.1.1 Legend: "¡ALTO! LEA LA ETIQUETA Y EL PANFLETO ANTES DE USAR EL PRODUCTO, CONSULTE AL PROFESIONAL EN CIENCAS AGRONÓMICAS", as defined in numeral 5.4.10.
9.2.1.2 Company logo (empresa): registration holder, formulator, or distributor (must be at the top and centered), as defined in numeral 5.1.8.
9.2.1.3 Brand (product name): concentration-formulation. Regarding formulation, only when applicable, as defined in numerals 3.16 and 5.4.1.
9.2.1.4 Class, group, or chemical family: as defined in numerals 3.1; 3.28, 5.4.2 and 5.4.2.1. For adjuvants, indicate only the class of adjuvants.
9.2.1.5 Common name of the active ingredient(s) or the component(s), as defined in numeral 3.20. For adjuvants, indicate only the common name of the component.
9.2.1.6 Chemical composition: as defined in numeral 5.4.4.
9.2.1.7 Contains: amount of active ingredient and components, as defined in numeral 5.4.7.
9.2.1.8 Density (for liquids): as defined in numeral 5.4.5.
9.2.1.9 Net content: as defined in numeral 5.4.8.
9.2.1.10 The pictogram (symbol) and "warning" word: according to its toxicological classification and category (CENTERED, UPPERCASE AND BOLD), as defined in numeral 6 and Table B.2 of Anexo B of this regulation.
9.2.1.11 Antidote: as defined in numeral 5.4.14.2.
9.2.1.12 Formulator: as defined in numeral 5.4.17.1.
9.2.1.13 "Warning" legend (single): "NO ALMACENAR ESTE PRODUCTO EN CASA DE HABITACIÓN. MANTÉNGASE BAJO LLAVE FUERA DEL ALCANCE DE LOS NIÑOS, PERSONAS CON DISCAPACIDAD MENTAL, ANIMALES, ALIMENTOS Y MEDICAMENTOS".
9.2.1.14 Symptoms of poisoning: as defined in numeral 5.4.14.3.
9.2.1.15 PRIMEROS AUXILIOS legend: EN CASO DE INGESTIÓN, EN CASO DE CONTACTO CON LA PIEL, EN CASO DE INHALACIÓN, EN CASO DE CONTACTO CON LOS OJOS, as defined in numeral 5.1.14. /5.4.16.1.
9.2.1.16 Legend: "NUNCA DE A BEBER NI INDUZCA EL VÓMITO A PERSONAS EN ESTADO DE INCONSCIENCIA": as defined in numeral 5.4.16.2, literal a.
9.2.1.17 Legend: "TRATAMIENTO MÉDICO" indicate the general or the specific procedure, as defined in numeral 5.4.16.2, literal b.
9.2.2 Back body The information corresponding to the back body must begin at the top of it and its order is as follows:
9.2.2.1 Legend: "PROTEJA EL AMBIENTE CON BUENAS PRÁCTICAS AGRÍCOLAS".
9.2.2.2 Legend: "NO CONTAMINE RÍOS, LAGOS Y ESTANQUES CON ESTE PRODUCTO CON ENVASES O EMPAQUES VACÍOS".
9.2.2.3 Warranty notice: as defined in numeral 5.4.19.
9.2.2.4 Country and registration number: as defined in numeral 5.4.17.2.
9.2.2.5 Batch number: as defined in numeral 5.4.17.3.1.
9.2.2.6 Formulation date: as defined in numeral 5.4.17.3.2.
9.2.2.7 Expiry date: as defined in numeral 5.4.17.3.3.
9.3 Three-body label 9.3 Three-body label The three-body label applies to products whose container or package has a capacity greater than half a liter or half a kilogram; for this label, a pamphlet must be presented only when the related substance, adjuvant, or physical carrier is toxic to birds, livestock, bees, fish, crustaceans, according to the ecotoxicity exhibited by the product.
Along the length of the three bodies of the label, the following legend must be added:
"¡ALTO! LEA LA ETIQUETA Y EL PANFLETO ANTES DE USAR EL PRODUCTO, CONSULTE AL PROFESIONAL EN CIENCIAS AGRONÓMICAS", as defined in numeral 5.4.11.
9.3.1 Left body The information corresponding to the left body must begin at the top of it and in the following order:
9.3.1.1 Legend: "PRECAUTIONS AND USE WARNINGS", as defined in subsection 5.4.15.
9.3.1.2 Personal protective equipment to be used and precautionary measure: as defined in subsection 5.4.15.
9.3.1.3 Legend (single): "IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTER AND PROVIDE THE LABEL OR PAMPHLET", as defined in subsection 5.4.14.1.
9.3.1.4 Symptoms of poisoning: as defined in subsection 5.4.14.3.
9.3.1.5 First aid legend: IN CASE OF INGESTION: IN CASE OF SKIN CONTACT: IN CASE OF INHALATION: IN CASE OF EYE CONTACT: as defined in subsections 5.1.14 and 5.4.16.1.
9.3.1.6 Legend: "NEVER GIVE ANYTHING TO DRINK NOR INDUCE VOMITING TO PERSONS IN AN UNCONSCIOUS STATE", as defined in subsection 5.4.16.2, paragraph a. Legend: "MEDICAL TREATMENT", as defined in subsection 5.4.16.2, paragraph b.
9.3.1.7 Legend: "STORAGE AND TRANSPORT": indicate the physicochemical hazards (explosive, corrosive, and flammable, among others), instructions on the storage and transport conditions of the product. As defined in subsections 8.13 and 8.14.
9.3.2 Central Body The information corresponding to the central body must begin at the top of the same and in the following order:
9.3.2.1 Company logo (enterprise): registration holder, formulator, or distributor. It must be at the top and centered, as defined in subsection 5.1.8.
9.3.2.2 Brand (product name): concentration, formulation. In the case of the formulation, only when applicable, as defined in subsections 3.16 and 5.4.1.
9.3.2.3 Class, group, or chemical family: as defined in subsections 3.1, 3.28, 5.4.2, and 5.4.2.1. For adjuvants, indicate only the adjuvant class.
9.3.2.4 Common name of the active ingredient(s) or component(s): as defined in subsections 3.20 and 5.4.3. For adjuvants, indicate only the common name of the component.
9.3.2.5 Chemical composition: as defined in subsection 5.4.4.
9.3.2.6 Contains: amount of active ingredient or components for adjuvants, as defined in subsection 5.4.7.
9.3.2.7 Density (for liquids): as defined in subsection 5.4.5.
9.3.2.8 Net content: as defined in subsection 5.4.8.
9.3.2.9 The pictogram (symbol) and "warning" word: according to its toxicological classification and category (CENTERED, UPPERCASE AND BOLD LETTERS), as defined in subsection 6 and Table B2 of Annex B, of this regulation.
9.3.2.10 Antidote: as defined in subsection 5.4.14.2.
9.3.2.11 Formulator: as defined in subsection 5.4.17.1.
9.3.3 Right Body The information corresponding to the right body must begin at the top of the same and in the following order:
9.3.3.1 Legend: "COMPLY WITH THE RECOMMENDATIONS GIVEN ON THE LABEL AND PAMPHLET". "PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES". (CENTERED, IN UPPERCASE AND BOLD).
9.3.3.2 Legend: "DO NOT CONTAMINATE RIVERS, LAKES, AND PONDS WITH THIS PRODUCT, OR WITH EMPTY CONTAINERS OR PACKAGES". (CENTERED, IN UPPERCASE AND BOLD).
9.3.3.3 Legend: MANAGEMENT OF THE PRODUCT ONCE USED: (left-aligned), indicate the procedure for eliminating waste and disposing of empty containers and packages.
9.3.3.4 RECOMMENDED APPLICATION EQUIPMENT: (left-aligned), indicate equipment and procedure for application in the case of related substances and their action on the equipment. For adjuvants and physical carriers when applicable.
9.3.3.5 AGRONOMIC USE: (left-aligned).
- MIXTURE PREPARATION METHOD: (except for physical carriers).
- CROPS AND PESTS TO BE CONTROLLED: (when applicable), adjuvants are excepted.
- DOSAGE: (per hectare/manzana).
- DOSAGE RATE: (in the case of fumigants).
- USE INSTRUCTIONS AND APPLICATION METHODS: (for physical carriers: distribution and manner of placing the product in the crop, field, and controlled environment as applicable, and number of units per hectare).
- APPLICATION TIMING AND FREQUENCY: (except for adjuvants).
- RE-ENTRY INTERVAL TO THE TREATED AREA: (except for adjuvants).
- PRE-HARVEST INTERVAL: (interval between the last application and harvest).
9.3.3.6 Phytotoxicity:
9.3.3.7 Compatibility:
9.3.3.8 Warranty notice: as defined in subsection 5.4.18.
9.3.3.9 Importer: according to subsection 11.37. If required, the information may be included in a pamphlet, in accordance with the provisions of subsection 10.
9.3.3.10 Country and registration number: as defined in subsection 5.4.17.2.
9.3.3.11 Lot number: as defined in subsection 5.4.17.3.1.
9.3.3.12 Formulation date: as defined in subsection 5.4.17.3.2.
9.3.3.13 Expiration date: as defined in subsection 5.4.17.3.3.
NOTES:
1. The color band must be located along the entire length of the label, as defined in subsection 6 and Table B.3 of Annex B, of this regulation.
2. The pictograms shall be placed to the right of the corresponding legends. If the required information cannot be placed in the established order, it must be placed within the space of the body of the label.
3. In the case of physical carriers, the label must identify the package in which they are marketed, indicating the weight and the quantity of units contained in the package, so that the user using the product has the information contained on the label available.
10. PAMPHLET FORMAT FOR RELATED SUBSTANCES, ADJUVANTS, AND PHYSICAL CARRIERS FOR AGRICULTURAL USE This pamphlet format applies to one-body and two-body labels. For three-body labels, a pamphlet must be submitted only when the related substance, adjuvant, or physical carrier is toxic to birds, livestock, bees, fish, or crustaceans, according to the ecotoxicity presented by the product. The information must appear in the following order:
10.1 For a product requiring a pamphlet, the label must have the following legend:
"STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT AN AGRONOMIC SCIENCES PROFESSIONAL" (CENTERED, IN UPPERCASE AND BOLD LETTERS), as defined in subsection 5.4.11.
10.2 Company logo (enterprise): registration holder, formulator, or distributor (must be at the top and centered), as defined in subsection 5.1.8.
10.3 Brand (product name): concentration-formulation. In the case of the formulation, only when applicable, as defined in subsection 3.16.
10.4 Class, group, or chemical family: as defined in subsections 3.1 and 3.28. For adjuvants, indicate only the class.
10.5 Common name of the active ingredient(s) or component(s): for adjuvants, as defined in subsection 3.20.
10.6 Density (for liquids): as defined in subsection 5.4.5.
10.7 The pictogram (symbol) and "warning" word: according to its toxicological classification and category (CENTERED, UPPERCASE AND BOLD LETTERS), as defined in subsection 6 and Table B.2. of Annex B.
10.8 Legend "ANTIDOTE": indicate the general or specific procedure, as defined in subsections 5.4.14.2.
10.9 Solvent: indicate when applicable, as indicated in subsection 5.4.4, paragraph c.
10.10 Under the title "AGRONOMIC USE" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the agronomic use of the product must be indicated.
- MODE OF ACTION: As indicated in subsection 3.18.
- APPLICATION EQUIPMENT: recommended for the application of related substances and their action on the equipment. For adjuvants and physical carriers when applicable. Take into consideration subsections 11.13, 11.13.1, and 11.13.2.
- MIXTURE PREPARATION METHOD: (except for physical carriers). Take into consideration subsection 11.14.
- USE RECOMMENDATIONS: Take into consideration subsection 11.15.
- CROPS AND PESTS TO BE CONTROLLED: (except for adjuvants).
- DOSAGE: (per hectare/manzana).
- DOSAGE RATE: (in the case of fumigants).
- USE INSTRUCTIONS AND APPLICATION METHODS: (for physical carriers: distribution and manner of placing the product in the crop, field, and controlled environment as applicable, and number of units per hectare).
- APPLICATION TIMING AND FREQUENCY: (except for adjuvants).
- PRE-HARVEST INTERVAL (interval between the last application and harvest): take into consideration subsection 11.17.
- RE-ENTRY INTERVAL TO THE TREATED AREA (except for adjuvants): take into consideration subsection 11.18.
10.11 Phytotoxicity: (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS). Take into consideration subsection 11.19.
10.12 Compatibility: (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS). Take into consideration subsection 11.20.
10.13 Legend: PRECAUTIONS AND USE WARNINGS, as defined in subsection 5.4.15: (LEFT-ALIGNED AND IN BOLD), and its respective pictogram (Annex C, paragraph C).
- DO NOT STORE THIS PRODUCT IN DWELLING HOUSES. KEEP UNDER LOCK AND KEY, OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD, AND MEDICINES.
- USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, DURING MIXTURE PREPARATION, LOADING, AND APPLICATION: RUBBER GLOVES AND BOOTS, MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT, AND AN APRON MADE OF IMPERMEABLE MATERIAL (if additional or specific equipment is required, the registrant must indicate it, according to the product's characteristics).
- DO NOT EAT, SMOKE, OR DRINK DURING THE HANDLING OF THIS PRODUCT. BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES.
10.14 Legend: "STORAGE AND TRANSPORT" indicate the physicochemical hazards (explosive, corrosive, flammable, others), instructions on the storage and transport conditions of the product.
10.15 Legend: "IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTER AND PROVIDE THE LABEL AND PAMPHLET" (CENTERED, IN UPPERCASE AND BOLD), as defined in subsection 5.4.14.1.
10.16 SYMPTOMS OF POISONING: as defined in subsection 5.4.14.3.
10.17 FIRST AID: (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), indicate below:
- IN CASE OF INGESTION: as defined in subsections 5.1.14/5.4.16.1.
- IN CASE OF SKIN CONTACT: 5.1.14/5.4.16.1 - IN CASE OF INHALATION: 5.1.14/5.4.16.1.
- IN CASE OF EYE CONTACT: 5.1.14/5.4.16.1.
10.18 Legend: "NEVER GIVE ANYTHING TO DRINK NOR INDUCE VOMITING TO PERSONS IN AN UNCONSCIOUS STATE", as defined in subsection 5.4.16.2, paragraph a).
10.19 MEDICAL TREATMENT: as defined in subsection 5.4.16.2, paragraph b.
10.20 NATIONAL POISON CENTERS: as defined in subsection 11.29.
10.21 ENVIRONMENTAL PROTECTION: (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), under this title, indicate legends when applicable: TOXIC TO LIVESTOCK, TOXIC TO BIRDS, TOXIC TO BEES, TOXIC TO FISH AND CRUSTACEANS, with their respective pictogram right-aligned, Annex C, paragraph D, see subsection 5.4.13.
10.22 Legend "PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES": (CENTERED, IN UPPERCASE AND BOLD), as defined in subsection 5.4.12 "DO NOT CONTAMINATE RIVERS, LAKES, AND PONDS WITH THIS PRODUCT OR WITH EMPTY CONTAINERS OR PACKAGES", (CENTERED, IN UPPERCASE AND BOLD), as defined in subsection 5.4.13 10.23 Legend: "MANAGEMENT OF THE PRODUCT ONCE USED: (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), indicate the procedure for eliminating waste and disposing of empty containers and packages. Following this legend, place the Triple Wash pictogram at the bottom, when applicable according to the type and material of the container and formulation.
10.24 Below the Triple Wash pictogram (when applicable), according to Annex C, paragraph E, the legend must be included: "THE USE OF CONTAINERS OR PACKAGES IN A MANNER DIFFERENT FROM THAT FOR WHICH THEY WERE DESIGNED ENDANGERS HUMAN HEALTH AND THE ENVIRONMENT" (centered, in uppercase and bold letters).
10.25 Under the title "WARRANTY NOTICE" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the concessions that the formulator, registrant/distributor, offer for the product warranty must be indicated, as defined in subsection 5.4.18.
10.26 Formulator: as defined in subsection 5.4.17.1.
10.27 Importer: as defined in subsection 11.37.
10.28 Country and registration number: as defined in subsection 5.4.17.2.
11. PAMPHLET FORMAT FOR FORMULATED CHEMICAL PESTICIDES.
11.1 The legend "STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT AN AGRONOMIC SCIENCES PROFESSIONAL": which must be CENTERED, IN UPPERCASE AND BOLD, as defined in subsection 5.4.10.
11.1.1 Company logo (enterprise): registration holder, formulator, or distributor (must be at the top and centered), as defined in subsection 5.1.8.
11.2 Brand (product name): followed by the concentration of the active ingredient, expressed in numbers and the acronyms of the pesticide formulation, as defined in subsection 3.16.
11.3 Class, group, or chemical family of the pesticide: as defined in subsections 3.1, 3.28, 5.4.2, 5.4.2.1.
11.4 For pesticide mixtures: comply with what is indicated in 5.4.2.1.
11.5 Common name of the active ingredient: (CENTERED, IN UPPERCASE AND BOLD), as defined in subsections 3.20 and 5.4.3.
11.6 The pictogram (symbol) and warning word: according to its toxicological classification and category (CENTERED, UPPERCASE AND BOLD LETTERS), according to subsection 6 and Table B.2 of Annex B, of this regulation.
11.7 Following the legend: "ANTIDOTE" (CENTERED, IN UPPERCASE AND BOLD), the provisions of subsection 5.4.14.2 must be met.
11.8 Under the title "SOLVENT": it must be indicated if the formulation contains a hydrocarbon-type solvent, declaring its chemical name, according to subsection 5.4.4. c.
11.9 The density value of the product must be declared when it is a liquid and the temperature at which it was measured, followed by the title "DENSITY": (CENTERED, IN UPPERCASE AND BOLD). In the case of multiple packages, it must be indicated separately for each of the liquid formulations comprising it, according to subsection 5.4.5.
11.10 The following legends must appear centered in uppercase and bold letters:
11.10.1 "THIS PRODUCT MAY BE FATAL IF INGESTED OR INHALED. IT MAY CAUSE DAMAGE TO THE EYES AND SKIN THROUGH EXPOSURE".
DO NOT STORE THIS PRODUCT IN DWELLING HOUSES. KEEP UNDER LOCK AND KEY, OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD, AND MEDICINES.
11.10.2 The respective storage pictogram must be added, according to Annex C, paragraph A.
11.11 Under the title "AGRONOMIC USE": (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the agronomic use of the product must be indicated.
11.12 Under the title "MODE AND MECHANISM OF ACTION": (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), in the case of mode of action, indicate how the pesticide acts in the plant (example: it is systemic, contact, preventive, curative, multipurpose, post-emergent, pre-emergent, among others). Furthermore, describe how the pesticide is translocated in the plant (via xylem or phloem, among others). In the case of the mechanism of action, indicate how the pesticide acts directly on the physiological processes of the pests (affects the nervous system, interrupts protein synthesis, among others), as defined in subsections 3.17 and 3.18.
11.13 Under the title "APPLICATION EQUIPMENT": (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the application equipment must be specified in detail according to the class, formulation type, and mode of action of the pesticide to be used, as well as the type of application equipment (sprayer, duster, tractor, helicopter, small aircraft, granule applicator, among others), type of application (ground or aerial).
11.13.1 The recommendation must be added that before using the equipment, it must be verified that it is in good working order, without leaks, and with correct calibration, as well as indicate the type of nozzle that must be used.
11.13.2 Subsequently, the activity pictograms must be placed. As defined in Annex C, paragraph B.
11.14 Under the title "MIXTURE PREPARATION METHOD" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the following must be indicated:
11.14.1 The procedure recommended by the manufacturer or formulator when applied alone or in mixture with other pesticides.
11.14.2 Cite the carrier for the mixture (water or oil).
11.14.3 If the product must be shaken and its conditions before being used to make the mixture.
11.14.4 Appropriate pH of the water or the mixture to be used, the latter in accordance with the type of product or the desired effect of the product on the plant.
11.14.5 That once the application is completed, the equipment must be washed.
11.14.6 The precaution and use warning pictograms must be placed according to the formulation type of the product. (See Annex C, paragraph C).
11.15 Under the title "USE RECOMMENDATIONS" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the following must be included:
- a)Uses authorized by country.
- b)The common name of the crop and the pest.
- c)The scientific name of the crop and the pest written in italic and bold letters.
- d)Recommended dosages including quantity of commercial product per unit area (ha and mz) and water volume, application timing or moment, and for seed treaters per kg of seed. Observations: additional information for the good use of the product, when applicable.
For the case of PHYSICAL CARRIERS, indicate the procedure for handling the finished product before, during, and after placing it in the field.
For this purpose, the information may be added using a table indicating: Country (ies):
Crop Pest Dose Observations 11.16 Under the "APPLICATION INTERVAL" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the interval in terms of time that must elapse between one application and another of the product must be indicated. Additionally, the maximum number of applications per crop cycle must be indicated.
For the case of PHYSICAL CARRIERS, the time that must elapse from one placement to another in the field must be indicated.
11.17 Under the title "INTERVAL BETWEEN THE LAST APPLICATION AND HARVEST" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), it must be indicated in terms of time how much must elapse between the last application of the pesticide and the harvest collection.
11.18 Under the title "RE-ENTRY INTERVAL TO THE TREATED AREA" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), it must be indicated in terms of time between the application of the pesticide and the entry of persons to the treated field or livestock grazing.
11.19 Under the title "PHYTOTOXICITY" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the application conditions under which the product may be phytotoxic to the recommended crops must be indicated.
11.20 Under the title "COMPATIBILITY" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), it must be indicated with which agrochemical products it is not compatible.
11.21 Under the title "PRECAUTIONS AND USE WARNINGS" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), indicate the personal protective equipment to be used and the precautionary measures, as defined in subsections 11.23, 11.24, 11.24.1, and 11.24.2.
11.22 Under the title "STORAGE AND TRANSPORT" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the manner in which the product must be transported and stored to avoid harm to human health, animals, or the environment must be indicated.
11.23 The legend "DO NOT STORE THIS PRODUCT IN DWELLING HOUSES. KEEP UNDER LOCK AND KEY, OUT OF THE REACH OF Crop Pest Dose Observations CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD, AND MEDICINES" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS). Additionally, the legend must be accompanied by the respective pictogram, Annex C, paragraph A (aligned to the right side).
11.24 Legends according to the application method:
11.24.1 Indicate any of the three legends described below, depending on the formulation type of the pesticide, and the respective pictogram(s) shall be used as applicable, the legend (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS) at the margin, and the pictogram(s) to the right.
- a)USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, LOADING, AND APPLICATION:
- GLOVES, RUBBER BOOTS, MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT, APRON MADE OF IMPERMEABLE MATERIAL.
- b)USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, DURING MIXTURE PREPARATION, LOADING, AND APPLICATION:
- GLOVES, RUBBER BOOTS, MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT, APRON MADE OF IMPERMEABLE MATERIAL.
- c)USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT AND ITS APPLICATION OR PLACEMENT:
- GLOVES, RUBBER BOOTS, MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT, APRON MADE OF IMPERMEABLE MATERIAL.
The ANC will approve protection measure legends different from the above, provided they are technically supported by the formulator.
11.24.2 Place the following legend (CENTERED, IN UPPERCASE AND BOLD LETTERS) "DO NOT EAT, SMOKE, OR DRINK DURING THE HANDLING AND APPLICATION OF THIS PRODUCT. BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES" and its respective pictogram.
11.25 Following the title "SYMPTOMS OF POISONING" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the product's own symptoms of poisoning must be indicated.
11.26 Under the title "FIRST AID" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), first aid must be indicated for each case: IN CASE OF INGESTION: IN CASE OF SKIN CONTACT: IN CASE OF INHALATION: and IN CASE OF EYE CONTACT: in the order indicated.
11.27 The legend must appear: "NEVER GIVE ANYTHING TO DRINK NOR INDUCE VOMITING TO PERSONS IN AN UNCONSCIOUS STATE" (CENTERED IN UPPERCASE AND BOLD).
11.28 Under the title "MEDICAL TREATMENT" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS). Indicate the general or specific procedure.
This title must be indicated according to subsection 5.4.16.2, paragraph b.
11.29 Under the title: "NATIONAL POISON CENTERS" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the full name of the institution in charge of attending to these types of emergencies, the name of the country, and the telephone numbers must be placed.
11.30 Under the title: "ENVIRONMENTAL PROTECTION" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the effects on the environment must be indicated as applicable: toxicity to birds, aquatic organisms, bees, earthworms, or other organisms, and their respective pictogram according to Annex C, (RIGHT-ALIGNED, IN UPPERCASE AND BOLD).
- TOXIC TO LIVESTOCK and its pictogram.
- TOXIC TO BIRDS and its pictogram.
- TOXIC TO FISH OR CRUSTACEANS and its pictogram.
- TOXIC TO BEES and its pictogram.
- DO NOT CONTAMINATE RIVERS, LAKES, AND PONDS WITH THIS PRODUCT, OR WITH EMPTY CONTAINERS OR PACKAGES, as defined in subsection 5.4.13.
11.31 It must be indicated if the product is persistent in soil or water, as well as the measures to follow in case of spills. Also indicate the physicochemical hazards presented by the product, such as flammability and corrosivity. Indicate mitigation measures, as applicable.
11.32 In the case of formulated chemical pesticides, the following legends must be included (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), as applicable:
- RESPECT THE PROTECTION AREAS OF RIVERS, STREAMS, AND OTHER FRAGILE AREAS.
- DO NOT APPLY THE PRODUCT UNDER CLIMATIC CONDITIONS THAT FAVOR RUNOFF OR DRIFT OF THE PRODUCT.
- ENSURE THAT THE PROTECTION AREAS OF WATER COURSES ADJACENT TO THE CROP HAVE PROTECTIVE BARRIERS (SUCH AS VEGETATION) THAT MINIMIZE THE DRIFT OF THE PRODUCT".
11.33 Under the title "MANAGEMENT OF CONTAINERS, PACKAGES, WASTE, AND REMNANTS" (left-aligned, in uppercase and bold letters), the procedure for the final disposal of these must be indicated, and place (When applicable according to the type and material of the container and formulation), the triple wash pictogram, centered. See Annex C, paragraph E.
NOTE 1: For the case of physical carriers with pesticides, the collection of said physical carriers after their use must also be indicated.
11.34 Below the Triple Wash pictogram, the legend must be included: "THE USE OF CONTAINERS OR PACKAGES IN A MANNER DIFFERENT FROM THAT FOR WHICH THEY WERE DESIGNED ENDANGERS HUMAN HEALTH AND THE ENVIRONMENT" (centered, in uppercase and bold letters).
11.35 Under the title "WARRANTY NOTICE" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the concessions that the formulator, registrant/distributor, offer for the product warranty must be indicated, according to subsection 5.4.18.
11.36 Under the title "FORMULATED BY" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the formulator must be indicated, according to subsection 5.4.17.1.
11.37 Under the title "IMPORTER" (LEFT-ALIGNED, IN UPPERCASE AND BOLD LETTERS), the name and full address, telephone number, and email of the importer must be indicated, according to subsection 3.10.
11.38 Country and registration number: according to subsection 5.4.17.2.
12. VERIFICATION AND SURVEILLANCE The surveillance and verification of this Central American Technical Regulation corresponds to the National Competent Authority of each of the State Parties.
13. FINAL PROVISIONS 13.1 Any label that has been approved or updated in any of the State Parties in accordance with this regulation will be accepted by the other State Parties upon presentation of the resolution or official approval letter from the ANC that approved it.
If the National Competent Authority (ANC) verifies that the label approved by one of the State Parties does not comply with the requirements, it will proceed to request that the label be corrected and approved in accordance with this regulation by the ANC that issued the resolution supporting the label recognition request.
13.2 The requirements expressed in this regulation represent the totality of requirements that the ANCs shall require for approving the labeling of the products regulated in this regulation.
14. TRANSITORY PROVISION 14.1 Transitory Provision I.
FOR REGULATED PARTIES: Regulated parties shall have a deadline until June 30, 2024 (*), to submit the Label and Pamphlet update requirements established in this regulation. In the case of Nicaragua, said deadline will be until December 31, 2021, to submit the Label and Pamphlet update requirements established in this regulation.
(*)(The previous date thus amended by Article 2 of Executive Decree No. 44682 of May 16, 2024, which approved Resolution No. 482-2023 (COMlECO-CV) of 5712/2023, which resolved that: "For the case of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama, the deadline established in subsection 14.1 Transitory Provision 1 of the Central American Technical Regulation will expire on June 30, 2024") FOR THE NATIONAL COMPETENT AUTHORITIES (ANC): Following the submission of the corresponding requirements by the regulated parties, the ANC will have a period of up to 1 year (12 months) to evaluate the information submitted by the regulated party and issue the Resolution of approval or denial of labels and pamphlets.
DEADLINE TO EXHAUST INVENTORIES OF LABELS AND PAMPHLETS:
Once the regulated party receives the approval Resolution from the ANC, they will have up to one year (12 months) to exhaust inventories of the labels and pamphlets. During the deadlines of this transitory provision, national and imported products may be marketed with the labels and pamphlets approved under previous regulations.
In case of non-compliance with any deadline indicated in this transitory provision, action shall be taken in accordance with the regulations of each State Party.
14.2 Transitory Provision II. Label and pamphlet authorization applications that had initiated the process in accordance with the legislation in force on their submission date will conclude the process under that regulation or may request to adhere to the new legislation and must comply with the deadline established in transitory provision I of this regulation for their update.
15. BIBLIOGRAPHY 15.1 Food and Agriculture Organization of the United Nations (FAO), Guidelines on Good Labeling Practice for Pesticides; Rome, 1995.
15.2 Organismo Internacional Regional de Sanidad Agropecuaria (OIRSA), Mandatory Harmonized Guideline for the Elaboration of the Label of Formulated Chemical Pesticides for Use in Agriculture in the countries of Central America (Costa Rica, El Salvador, Honduras, Guatemala, Nicaragua, and Panama), 2002.
15.3 United Nations Organization (UN), Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fifth Edition. New York and Geneva 2013.
(NORMATIVE) Acronyms of the pesticide formulation
| CODE | FORMULATION TYPE | CODE | FORMULATION TYPE |
|---|---|---|---|
| AB | Grain bait | GS | Grease |
| AE | Aerosol | GW | Water-soluble gel |
| AL | Ready-to-use liquids | HN | Hot fogging concentrate |
| AP | Ready-to-use powders | KK | Combined solid/liquid pack |
| BB | Block bait | KL | Combined liquid/liquid pack |
| BR | Controlled-release block | KN | Cold fogging concentrate |
| CB | Concentrated bait | KP | Combined solid/solid pack |
| CF | Capsule suspension for seed treatment | LA | Lacquer |
| LS | Solution for seed treatment | ||
| CL | Contact liquid or gel | ME | Micro-emulsion |
| CG | Encapsulated granules | MG | Micro-granule |
| CP | Contact powder | OF | Oil-miscible suspension |
| CS | Capsule suspension | OL | Oil-miscible liquid |
| DC | Dispersible concentrate | OP | Oil-dispersible powder |
| DP | Dry powder | PA | Paste |
| DS | Powder for dry seed treatment | PB | Disc bait |
| DT | Tablet for direct application | PC | Concentrated paste or gel |
| EC | Emulsifiable concentrate | PR | Impregnated stick |
| ED | Electrochargeable liquid | PS | Impregnated seed |
| EG | Emulsifiable granule | RB | Ready-to-use bait |
| EO | Emulsion, water in oil | SB | Chunk bait |
| ES | Emulsion for seed treatment | SC | Suspension concentrate |
| EW | Emulsion, oil in water | SE | Suspension-emulsion |
| FD | Smoke tin | SG | Water-soluble granules |
| FG | Fine granules | SL | Soluble concentrate |
| FK | Smoke flare | SO | Spreading oil |
| FP | Smoke cartridge | SP | Water-soluble powder |
| FR | Smoke rod | SS | Water-soluble powder for seed treatment |
| FS | Flowable concentrate for seed treatment | ST | Water-soluble tablets |
| SU | Suspension for ULV | ||
| FT | Smoke tablet | TB | Tablets |
| FU | Smoke generator | TC | Technical grade active ingredient |
| FW | Smoke pellet | TK | Technical concentrate |
| CODE | FORMULATION TYPE | CODE | FORMULATION TYPE |
| GA | Gas | TP | Replaced by CP |
| GB | Granular bait | UL | Liquid for ULV |
| GE | Gas generator | VP | Vapour releasing product |
| GF | Gel for seed treatment | WG | Water-dispersible granules |
| GG | Macro-granules | WP | Wettable powder |
| GL | Emulsifiable gel | WS | Water-dispersible powder for seed treatment |
| GP | Fine powder | WT | Wettable tablets |
| GR | Granule | XX | Others (new formulations) |
(NORMATIVE) Toxicological classification Classification Criteria for Substances Substances are classified into five hazard categories based on acute toxicity by oral, dermal, or inhalation exposure, according to the numerical criteria expressed as threshold values as shown in the following table:
Table B.1.
Acute toxicity hazard category
| Exposure Route | Category 1 | Category 2 | Category 3 | Category 4 | Category 5 |
|---|---|---|---|---|---|
| Oral (mg/kg body weight) | 5 | 50 | 300 | 2000 | 5000 |
| Dermal (mg/kg body weight) | 50 | 200 | 1000 | 2000 | |
| Gases (ppmV) | 100 | 500 | 2500 | 20000 | >20000 |
| Vapours (mg/l) | 0.5 | 2.0 | 10.0 | 20.0 | >20.0 |
| Dust and mists (mg/l) | 0.05 | 0.5 | 1.0 | 5.0 | >5.0 |
Source: GHS NOTES:
1. The concentration of gases is expressed in parts per million by volume (ppmV).
2. The acute toxicity values are expressed as (approximate) LD50 values (oral, dermal absorption) or LC50 (inhalation).
3. Acute Toxicity Classification Criteria. The numbers in the category columns should be read as follows, for example for oral toxicity: Category 1: ?5, Category 2: >5 and ?50, Category 3: >50 and ?300, Category 4: >300 and ? 2000, Category 5: >2000 and ? 5000.
Source: GHS/UNITAR UNITED NATIONS.
4. Products with an LD50 greater than 5000 mg/kg shall be classified in Category 5, for oral and dermal exposure.
5. When applying the toxicological classification for the different with the objective of protecting health and the environment, provided that said classification applies to the product being evaluated.
6. Inhalation toxicological classification (LC50) must be applied to those fumigant products that form mist, gas, vapours, or dust.
Table B.2.
Acute toxicity hazard category pictograms according to GHS.
| | Category 1 | Category 2 | Category 3 | Category 4 | Category 5 | | --- | --- | --- | --- | --- | --- | | Symbol | Skull and crossbones | Skull and crossbones | Skull and crossbones | Exclamation mark | No symbol | | Signal Word | Danger | Danger | Danger | Warning | Warning | Table B.3.
Toxicological band colour by acute toxicity hazard category according to FAO.
| Category | Band Colour |
|---|---|
| 1 | Red PMS 199-C |
| 2 | Red PMS 199-C |
| 3 | Yellow PMS 101-C |
| 4 | Blue PMS 293-C |
| 5 | Green PMS 347-C |
(NORMATIVE) Storage, activity, use precautions and warnings, environmental protection, and triple-rinse pictograms.
A. Storage:
B. Activity:
C. Use precautions and warnings:
D. Environmental protection:
E. Triple rinse
(NORMATIVE) 1. Pamphlet models for formulated chemical pesticides.
2. Label models for formulated chemical pesticides.
3. Pamphlet models for related substances, adjuvants (coadyuvantes), and physical vehicles (vehículos físicos).
4. Label models for related substances, adjuvants (coadyuvantes), and physical vehicles (vehículos físicos).
STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE AGRONOMIC SCIENCES PROFESSIONAL Ver 5.4.10 / 11.1 BRAND, CONCENTRATION - FORMULATION Ver /3.16 / 5.4.1/11.2 /11.4 CLASS, GROUP OR CHEMICAL FAMILY Ver 11.3 / 3.1/3.28/5.4.2/5.4.2.1.
COMMON NAME OF THE ACTIVE INGREDIENT(S) Ver 11.5 /3.20/5.4.3 SIGNAL WORD Ver 11. 6/Annex B table B.2.
ANTIDOTE: NONE AVAILABLE OR STATE THE ANTIDOTE Ver 11. 7/5.4.14.2 SOLVENT: state only if it is a hydrocarbon Ver 11.8 /5.4.4.c.
DENSITY: (liquids) Ver 11. 9/5.4.5 THIS PRODUCT MAY BE FATAL IF SWALLOWED OR INHALED MAY CAUSE EYE AND SKIN DAMAGE UPON EXPOSURE.
DO NOT STORE THIS PRODUCT IN DWELLING HOUSES.
KEEP LOCKED UP AND OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD, AND MEDICINES Ver 11.10.1 Storage pictogram Ver 11.10.2/Annex C paragraph a AGRONOMIC USE: Ver 11.11.
MODE AND MECHANISM OF ACTION: Ver 11.12/3.17/3.18.
APPLICATION EQUIPMENT: Ver 11.13. / 11.13.1/11.13.2. (Pictogram to the right).
METHOD OF PREPARATION OF THE MIXTURE: Ver 11.14.
USE RECOMMENDATIONS: Ver 11.15 APPLICATION INTERVAL: Ver 11.16 ENVIRONMENTAL PROTECTION: Place pictogram (to the right) as applicable, Ver 11.30 PRE-HARVEST INTERVAL (intervalo entre la última aplicación y la cosecha): Ver 11.17 TOXIC TO LIVESTOCK Ver 11.30/5.4.13/Annex C paragraph d RE-ENTRY INTERVAL TO THE TREATED AREA: Ver 11.18 TOXIC TO BIRDS Ver 11.30/5.4.13/Annex C paragraph d PHYTOTOXICITY: Ver 11.19 COMPATIBILITY: Ver 11.20 TOXIC TO FISH OR CRUSTACEANS Ver 11.30/5.4.13/Annex C paragraph d USE PRECAUTIONS AND WARNINGS: Ver 11.21 TOXIC TO BEES Ver 11.30/5.4.13/Annex C paragraph d Personal protective equipment, precautionary measures, management of empty containers/packaging (envases/empaques) and spills.
DO NOT CONTAMINATE RIVERS, LAKES AND PONDS WITH THIS PRODUCT OR WITH EMPTY CONTAINERS OR PACKAGING (envases o empaques). Ver 11.30/5.4.13 DO NOT STORE THIS PRODUCT IN DWELLING HOUSES. KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES. Place legend (LEFT-ALIGNED, IN UPPERCASE AND BOLD) in the margin and the pictogram(s) to the right. Ver 11.23/Annex C, paragraph A.
Indicate if the product is persistent in soil or water. Measures in case of spills and collection of containers/ packaging (envases/empaques) or waste. Indicate physical-chemical hazards such as flammability and corrosivity. Mitigation measures as applicable. Ver 11.31 RESPECT RIVER PROTECTION AREAS, STREAMS AND OTHER FRAGILE AREAS. Ver 11.32 DO NOT EAT, SMOKE OR DRINK DURING THE HANDLING AND APPLICATION OF THIS PRODUCT. BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES.
Ver 11.24.2 STORAGE AND TRANSPORT:
Ver 11.22 DO NOT APPLY THE PRODUCT UNDER WEATHER CONDITIONS THAT FAVOUR PRODUCT RUNOFF OR DRIFT.
SYMPTOMS OF POISONING: Ver 11.25 FIRST AID: Ver 11.26 IF SWALLOWED: Ver 11.26/5.1.14 IN CASE OF CONTACT WITH SKIN:
Ver 11.26/5.1.14 ENSURE THAT THE PROTECTION AREAS OF WATERCOURSES ADJACENT TO THE CROP HAVE PROTECTION BARRIERS (SUCH AS VEGETATION) THAT MINIMIZE PRODUCT DRIFT.
IF INHALED: Ver 11.26/5.1.14 IN CASE OF CONTACT WITH EYES: Ver 11.26/5.1.14 MANAGEMENT OF CONTAINERS, PACKAGING (EMPAQUES), WASTE AND REMNANTS: Ver 11.33 Annex C, paragraph e.
NEVER GIVE DRINK OR INDUCE VOMITING TO UNCONSCIOUS PERSONS Ver 11.27 USING CONTAINERS OR PACKAGING (ENVASES O EMPAQUES) IN A WAY DIFFERENT FROM WHAT THEY WERE DESIGNED FOR ENDANGERS HUMAN HEALTH AND THE ENVIRONMENT. Ver 11.34 MEDICAL TREATMENT: If none, indicate: NONE AVAILABLE and indicate the required medical treatment. Ver 11.28.
NATIONAL POISON CENTERS Ver 11.29 WARRANTY NOTICE: Ver 11.35/ 5.4.19
| COUNTRY | INSTITUTION | TELEPHONES |
|---|---|---|
| Guatemala | Centro de | (502) 2251- |
| Información y | 3560/2232- | |
| Asistencia | 0735 | |
| Toxicológica | ||
| El | Hospital | (503) 2231- |
| Salvador | Nacional | 9262 |
| Rosales | ||
| Honduras | Hospital | (504) 232- |
| Escuela | 6105 | |
| Nicaragua | Centro Nacional de Toxicología | (505) 2289- 4700 ext. 1294 cel. 8755-0983 |
| Costa | Centro Nacional | (506) 2223- |
| Rica | de | 1028 |
FORMULATED BY: Ver 11.36/5.4.17.1 IMPORTER: Ver 11.37 COUNTRY AND REGISTRATION NUMBER Ver 11. 38/ 5.4.17.2
| Intoxicaciones | ||
|---|---|---|
| Panamá | Centro de Investigación e Información de Medicamentos y Tóxicos | (507) 523- 4948 |
ONE-PIECE LABEL FORMAT FOR A FORMULATED CHEMICAL PESTICIDE STOP! READ THE LABEL AND PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES. Ver 5.4.10 COMPANY LOGO. Ver 5.1.8 BRAND, CONCENTRATION - FORMULATION Ver 3.16 Pesticide class-chemical group or family Ver 3.1/3.28/5.4.2 ISO common name of the active ingredient Ver 3.20/5.4.3 Chemical composition % w/v or w/w Ver 5.4.4 IUPAC name of the active ingredient 00.00 see 5.4.4 a Inert ingredients (Ingredientes inertes) 00.00 see 5.4.4 b Solvents (if hydrocarbon-based) see 5.4.4 c Contains: grams of active ingredient per litre or kilogram of commercial product see 5.4.7 DENSITY: (liquids) Ver 5.4.5 Net content: (grams, kilograms, millilitres, litres) Ver 5.4.8 WARNING PICTOGRAM (SYMBOL) Ver numeral 6 and Table B.2 of Annex B SIGNAL WORD Ver numeral 6, Table B.2 of ANNEX B IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTRE AND PROVIDE THE LABEL AND THE PAMPHLET Ver 5.4.14.1 ANTIDOTE: NONE AVAILABLE OR STATE ANTIDOTE Ver 5.4.14.2 | FORMULATOR: Ver 5.4.17.1 COUNTRY AND REGISTRATION NUMBER Ver 5.4.17.2 BATCH NUMBER: Ver 5.4.17.3.1. DATE OF FORMULATION: Ver 5.4.17.3.2 EXPIRY DATE: Ver 5.4.17.3.3 | | | --- | --- | | Place toxicological band colour according to numeral 6 and table B.3 of ANNEX B, of this regulation | | 2-PIECE LABEL FORMAT FOR A FORMULATED CHEMICAL PESTICIDE | FRONT PIECE | | --- | | STOP! READ THE LABEL AND PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES. Ver 5.4.10 | | COMPANY LOGO. Ver 5.1.8 BRAND, CONCENTRATION - FORMULATION Ver 3.16 Pesticide class-chemical group or family Ver 3.1/3.28/5.4.2 ISO common name of the active ingredient Ver 3.20/5.4.3 Chemical composition % w/v or w/w Ver 5.4.4 IUPAC name of the active ingredient 00.00 see 5.4.4 a Inert ingredients (Ingredientes inertes) 00.00 see 5.4.4 b Solvents (if hydrocarbon-based) see 5.4.4 c Contains: grams of active ingredient per litre or kilogram of commercial product see 5.4.7 DENSITY: (liquids) Ver 5.4.5 Net content: (grams, kilograms, millilitres, litres) Ver 5.4.8 WARNING PICTOGRAM (SYMBOL) Ver numeral 6 and Table B.2 of Annex B | SIGNAL WORD Ver numeral 6, Table B.2 of ANNEX B IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTRE AND PROVIDE THE LABEL AND THE PAMPHLET Ver 5.4.14.1 ANTIDOTE: NONE AVAILABLE OR STATE ANTIDOTE Ver 5.4.14.2 FORMULATOR: Ver 5.4.17.1 USE PRECAUTIONS AND WARNINGS: Ver 5.4.15 DO NOT STORE THIS PRODUCT IN DWELLING HOUSES. KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES. Ver 5.4.15 (Storage pictogram to the right) USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, DURING MIXTURE PREPARATION, LOADING, AND APPLICATION: RUBBER GLOVES AND BOOTS, FACE MASK, HAT, EYE PROTECTION, LONG-SLEEVED SHIRT AND PANTS, AND WATERPROOF APRON. Ver 5.4.15 (Pictograms of use precautions and warnings to the right) DO NOT EAT, SMOKE OR DRINK DURING THE HANDLING OF THIS PRODUCT. BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES. Ver 5.4.15 (Pictogram to the right) SYMPTOMS OF POISONING: Indicate the characteristic symptoms of poisoning caused by the pesticide Ver 5.4.14.3.
FIRST AID: Ver 5.1.14/5.4.16.1 IF SWALLOWED:
IN CASE OF CONTACT WITH SKIN: IF INHALED:
IN CASE OF CONTACT WITH EYES:
NEVER GIVE DRINK OR INDUCE VOMITING TO UNCONSCIOUS PERSONS Ver 5.4.16.2 a. (Centred, uppercase and bold) MEDICAL TREATMENT: State the general or specific procedure. Ver 5.4.16.2 b.
Place toxicological band colour according to numeral 6 and table B.3 of ANNEX B, of this regulation | BACK PIECE | | --- | | STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES. FOLLOW THE RECOMMENDATIONS GIVEN ON THE LABEL AND THE PAMPHLET. PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES. Ver 5.4.12 | | ENVIRONMENTAL PROTECTION Ver 5.4.13 PICTOGRAMS (SYMBOL) Ver ANNEX C paragraph D. TOXIC TO LIVESTOCK: TOXIC TO BIRDS: TOXIC TO BEES: TOXIC TO FISH OR CRUSTACEANS: CONTAINER MANAGEMENT (Manejo de envases): Ver 5.4.13 / Annex C, paragraph E. DO NOT CONTAMINATE RIVERS, LAKES AND PONDS WITH THIS PRODUCT, WITH EMPTY CONTAINERS OR PACKAGING (envases o empaques). Ver 5.4.13 WARRANTY NOTICE: Ver 5.4.18 COUNTRY AND REGISTRATION NUMBER Ver 5.4.17.2 BATCH NUMBER: Ver 5.4.17.3.1 DATE OF FORMULATION: Ver 5.4.17.3.2 EXPIRY DATE: Ver 5.4.17.3.3 | | Toxicological band colour according to numeral 6 and table B.3 of ANNEX B of this regulation | LEFT PIECE CENTRAL PIECE RIGHT PIECE USE PRECAUTIONS AND WARNINGS:
Ver 5.4.15 DO NOT STORE THIS PRODUCT IN DWELLING HOUSES.
KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES Ver 5.4.15/The pictogram from Annex C, paragraph A, must be used.
USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, DURING PREPARATION OF THE MIXTURE, LOADING AND APPLICATION: RUBBER GLOVES AND BOOTS, FACE MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT AND WATERPROOF APRON (if additional or specific equipment is required, the registrant must indicate it, according to the product's characteristics).
DO NOT EAT, SMOKE OR DRINK DURING THE HANDLING OF THIS PRODUCT. BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES (5.4.15) Ver 5.4.15/Annex C, paragraph C.
*NOTE. This protective equipment and pictogram will be defined by the product formulator according to the physical or chemical properties of the same.
IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTRE AND PROVIDE THE LABEL AND THE PAMPHLET Ver 5.4.14.1 SYMPTOMS OF POISONING: Indicate the characteristic symptoms of the poisoning caused by the pesticide. Ver 5.4.14.3.
FIRST AID: Ver 5.4.16.1 / 5.1.14 IF SWALLOWED:
IN CASE OF CONTACT WITH SKIN:
IF INHALED:
IN CASE OF CONTACT WITH EYES:
NOTE: These indications may be expanded, depending on the toxicity and some physical and chemical characteristics of the substances, as well as the formulator's recommendations. Ver 5.1.14.
NEVER GIVE DRINK, NOR INDUCE VOMITING, TO UNCONSCIOUS PERSONS see 5.4.16.2 paragraph a.
MEDICAL TREATMENT:
Indicate the general procedure or the specific one if an antidote exists. Ver 5.4.16.2 paragraph b.
COMPANY LOGO. Ver 7.3.3 paragraph a / 5.1.8 Brand, concentration, formulation Ver 3.16/5.4.1 Class - chemical group or family Ver 3.1/ 3.28/ 5.4.2 / 5.4.2.1 ISO common name of the active ingredient.
Ver 3.20/5.4.3 Chemical composition % w/v or % w/w Ver 5.4.4 IUPAC name of the active ingredient 00.00 Ver 5.4.4 a Inert ingredients (Ingredientes inertes) 00.00 Ver 5.4.4 b Solvents (if hydrocarbon-based) Ver 5.4.4 c Contains: grams of active ingredient per litre or kilogram of commercial product Ver 5.4.7 DENSITY: (liquids) Ver 5.4.5 Net content: (grams, kilograms, millilitres, litres) Ver 5.4.8 WARNING PICTOGRAM (SYMBOL) Ver numeral 6 Table B.2 of Annex B SIGNAL WORD Ver numeral 6, Table B.2 of ANNEX B, ANTIDOTE: OR STATE NONE AVAILABLE Ver 5.4.14.2 FORMULATOR: Ver 5.4.17.1 FOLLOW THE RECOMMENDATIONS GIVEN ON THE LABEL AND THE PAMPHLET PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES. Ver 5.4.12 ENVIRONMENTAL PROTECTION: Ver 5.4.13 TOXIC TO LIVESTOCK: Ver 5.4.13 and
TOXIC TO BIRDS:
Ver 5.4.13 and Annex C, paragraph D.
TOXIC TO BEES: Ver 5.4.13 and
TOXIC TO FISH OR CRUSTACEANS: Ver 5.4.13 and Annex C, paragraph D.
CONTAINER MANAGEMENT (Manejo de envases): Ver 5.4.13 /
DO NOT CONTAMINATE RIVERS, LAKES AND PONDS WITH THIS PRODUCT, WITH EMPTY CONTAINERS OR PACKAGING (envases o empaques).
Ver 5.4.13 WARRANTY NOTICE:
Ver 5.4.18 COUNTRY AND REGISTRATION NUMBER Ver 5.4.17.2 BATCH NUMBER:
Ver 5.4.17.3.1 DATE OF FORMULATION Ver 5.4.17.3.2 DATE: Ver 5.4.17.3.3 STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES Ver 10.1/5.4.10 BRAND, CONCENTRATION - FORMULATION Ver 10.3/3.16 / 5.4.1 CLASS, CHEMICAL GROUP OR FAMILY Ver 10.4/ 3.1/3.28/5.4.2/5.4.2.1.
COMMON NAME OF THE ACTIVE INGREDIENT(S), THE COMPONENT(S).
Ver 10.5/3.20/5.4.3 DENSITY: (liquids) Ver 10.6/5.4.5 SIGNAL WORD Ver 10.7/Annex B table B.2 and 5.4.9 ANTIDOTE: NONE AVAILABLE OR STATE THE ANTIDOTE Ver 10.8/5.4.14.2 SOLVENT: (Declare hydrocarbon-based solvents when they are contained.) Ver 9.1.6/10.9 AGRONOMIC USE: Ver 10.10 MODE OF ACTION: Ver 10.10/3.18.
APPLICATION EQUIPMENT: Ver 10.10 For adjuvants (coadyuvantes) and physical vehicles (vehículos físicos) when applicable.
Take into consideration numeral 11.13/11.13.1/11.13.2. / (Pictograms to the right, when applicable, see Annex C, paragraph B).
METHOD OF MIXTURE PREPARATION (except physical vehicles): Ver 10.10/11.14.
USE RECOMMENDATIONS: (Ver 10.10/11.15) CROPS AND PESTS TO CONTROL:
(except adjuvants (coadyuvantes)).
DOSE: (per hectare/manzana) DOSAGE: (in the case of fumigants) INSTRUCTIONS FOR USE AND APPLICATION METHODS: (for physical vehicles (vehículos físicos):
distribution and method of placing the product in the crop, field and controlled environment as the case may be and number of units per hectare) TIMING AND FREQUENCY OF APPLICATION:
(except adjuvants (coadyuvantes)).
PRE-HARVEST INTERVAL (intervalo entre la última aplicación y la cosecha) see 10.10/11.17.
RE-ENTRY INTERVAL TO THE TREATED AREA:(except adjuvants (coadyuvantes)) (Ver 10.10/ 11.18) PHYTOTOXICITY: (Ver 10.11/ 11.19) COMPATIBILITY: (Ver 10.12/11.20) USE PRECAUTIONS AND WARNINGS: (Ver 10.13/11.21/5.4.15) Personal protective equipment, precautionary measures, management of empty containers/packaging (envases/empaques) and spills.
DO NOT STORE THIS PRODUCT IN DWELLING HOUSES.
KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES (Ver 10.13) USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, DURING PREPARATION OF THE MIXTURE, LOADING AND APPLICATION: RUBBER GLOVES AND BOOTS, FACE MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT, WATERPROOF APRON. (if additional or specific equipment is required, the registrant must indicate it, according to the product's characteristics) (Ver 10.13).
DO NOT EAT, SMOKE OR DRINK DURING THE HANDLING AND APPLICATION OF THIS PRODUCT. BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES. (Ver 10.13).
STORAGE AND TRANSPORT: (Ver 10.14) IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTRE AND PROVIDE THE LABEL AND THE PAMPHLET (Ver 10.15/5.4.14.1) SYMPTOMS OF POISONING:
(Ver 10.16/ 5.4.14.3) FIRST AID: Ver 10.16 / 5.1.14 / 5.4.16.1 IF SWALLOWED: Ver 10.17/5.1.14 IN CASE OF CONTACT WITH SKIN: Ver 10.17/5.1.14/.5.4.16.1 IF INHALED: Ver 10.17/5.1.14/5.4.16.1 IN CASE OF CONTACT WITH EYES: Ver 10.17/5.1.14/5.4.16.1 NEVER GIVE DRINK NOR INDUCE VOMITING TO UNCONSCIOUS PERSONS Ver 10.18/5.4.16.2 paragraph a MEDICAL TREATMENT: Indicate the required medical treatment. Ver 19.19/ 5.4.16.2, paragraph b NATIONAL POISON CENTERS Ver 10.20/11.29
| COUNTRY | INSTITUTION | TELEPHONES |
|---|---|---|
| Guatemala | Centro de | (502) 2251- |
| Información y | 3560/ 2232- | |
| Asistencia | 0735 | |
| Toxicológica | ||
| El | Hospital | (503) 2231- |
| Salvador | Nacional Rosales | 9262 |
| Honduras | Hospital Escuela | (504) 232- 6105 |
| Nicaragua | Centro Nacional de Toxicología | (505) 2289- 4700 ext. 1294 cel. 8755-0983 |
| Costa Rica | Centro Nacional | (506) 2223- |
| de | 1028 | |
| Intoxicaciones | ||
| Panamá | Centro de | (507) 523- |
| Investigación e | 4948 | |
| Información de | ||
| Medicamentos y | ||
| Tóxicos |
ENVIRONMENTAL PROTECTION: Place pictogram as applicable. Ver 10.21/ 5.4.13 TOXIC TO LIVESTOCK Ver 10.21/5.4.13 TOXIC TO BIRDS Ver 10.21/5.4.13 TOXIC TO BEES Ver 10.21/5.4.13 TOXIC TO FISH OR CRUSTACEANS Ver 10.21/5.4.13 PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES see 10.22 DO NOT CONTAMINATE RIVERS, LAKES AND PONDS WITH THIS PRODUCT OR WITH EMPTY CONTAINERS OR PACKAGING (envases o empaques). see 10.22/5.4.13 MANAGEMENT OF THE PRODUCT ONCE USED see 10.23 USING CONTAINERS OR PACKAGING (ENVASES O EMPAQUES) IN A WAY DIFFERENT FROM WHAT THEY WERE DESIGNED FOR ENDANGERS HUMAN HEALTH AND THE ENVIRONMENT. Ver 10.24 WARRANTY NOTICE: Ver 10.25/ 5.4.18 FORMULATOR: Ver 10.26/5.4.17.1.
IMPORTER: Ver 10.27/11.37 COUNTRY AND REGISTRATION NUMBER Ver 10.28/5.4.17.2 | 1-PIECE LABEL FORMAT FOR RELATED SUBSTANCES, ADJUVANTS AND PHYSICAL VEHICLES (SUSTANCIAS AFINES, COADYUVANTES Y VEHÍCULOS FÍSICOS) | | | | --- | --- | --- | | STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES Ver 9.1.1/5.4.11 | | | | | COMPANY LOGO Ver 9.1.2/5.1.8 | | BRAND, CONCENTRATION - FORMULATION Ver 9.1.3 /3.16/5.4.1 CLASS - CHEMICAL GROUP OR FAMILY Ver 9.1.4/3.1/3.28/5.4.2/5.4.2.1 COMMON NAME OF THE ACTIVE INGREDIENT(S), THE (OR THE) COMPONENT(S) Ver 9.1.5/3.20/5.4.3 Chemical composition: Ver 9.1.6/5.4.4 %w/v or %w/w Chemical name of the active ingredient(s) or component (s)........00.00 Inert ingredients (Ingredientes inertes)...............................00.00 Solvent: (Declare hydrocarbon-based solvents when they are contained.)
Contains: grams of active ingredient per litre or kilogram of commercial product Ver 9.1.7/5.4.7 DENSITY: (Liquids) Ver 9.1.8/5.4.5 Net content: (grams, Kilograms, millilitres, litres) Ver 9.1.9/5.4.8 SIGNAL WORD Ver numeral 6 and Table B.2 of Annex B, and 5.4.9 ANTIDOTE: Ver 9.1.11/5.4.14.2 MEDICAL TREATMENT: Indicate the general or the specific procedure. Ver 9.1.12/5.4.16.2 paragraph b.
DO NOT STORE THIS PRODUCT IN DWELLING HOUSES.
KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES. (CENTRED, IN UPPERCASE AND BOLD).
Including its respective pictogram Ver 9.1.13 FORMULATOR: Ver 5.4.17.1/9.1.14 COUNTRY AND REGISTRATION NUMBER Ver 5.4.17.2/9.1.15 | 2-PIECE LABEL FORMAT FOR RELATED SUBSTANCES, ADJUVANTS AND PHYSICAL VEHICLES (SUSTANCIAS AFINES, COADYUVANTES Y VEHÍCULOS FÍSICOS) | | --- | | FRONT PIECE | | STOP! READ THE LABEL AND PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES Ver 9.2.1.1/5.4.10 | BRAND, CONCENTRATION - FORMULATION Ver 9.2.1.3/3.16/5.4.1 CLASS - CHEMICAL GROUP OR FAMILY Ver 9.2.1.4/3.1/ 3.28/5.4.2/5.4.2.1.
COMMON NAME OF THE ACTIVE INGREDIENT(S), THE OR THE COMPONENT(S). Ver 9.2.1.5/3.20/5.4.3 Chemical composition: Ver 9.2.1.6/5.4.4 %w/v or %w/w Chemical name of the active ingredient(s) or components...............................
.....00.00 Inert ingredients (Ingredientes inertes).
............................. . 00.00 Solvent: (Declare hydrocarbon-based solvents when they are contained.)
Contains: grams of active ingredient per litre or kilogram of commercial product. Ver 9.2.1.7/5.4.7 DENSITY: (Liquids) Ver 9.2.1.8/5.4.5 Net content: (grams, kilograms, millilitres, litres) Ver 9.2.1.9/ 5.4.8 SIGNAL WORD Ver numeral 6 and Table B.2 of Annex B and 5.4.9, 9.2.1.13 ANTIDOTE: Ver 9.2.11/5.4.14.2 FORMULATOR: Ver 9.2.1.12/5.4.17.1 DO NOT STORE IN DWELLING HOUSES.
KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES. Ver 9.2.1.13 SYMPTOMS OF POISONING: Indicate the characteristic symptoms of the poisoning caused by the product. Ver 9.2.1.14 / 5.4.14.3 FIRST AID: Ver 9.2.1.15/5.1.14/5.4.16.1 IF SWALLOWED:
IN CASE OF CONTACT WITH SKIN:
IF INHALED:
IN CASE OF CONTACT WITH EYES:
NOTE. These indications may be expanded, depending on the toxicity and some physical and chemical characteristics of the substances, as well as the recommendations of the formulator.
NEVER GIVE DRINK NOR INDUCE VOMITING TO UNCONSCIOUS PERSONS. Ver 9.2.1.16/5.4.16.2 paragraph a MEDICAL TREATMENT: Indicate the general or the specific procedure. Ver 9.2.1.17/5.4.16.2 paragraph b Toxicological band colour according to numeral 6 and Table B.3 of ANNEX B, of this regulation.
BACK PIECE STOP! READ THE LABEL AND THE PAMPHLET BEFORE USING THE PRODUCT, CONSULT THE PROFESSIONAL IN AGRONOMIC SCIENCES. FOLLOW THE RECOMMENDATIONS GIVEN ON THE LABEL AND THE PAMPHLET. PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES (CENTRED, IN UPPERCASE AND BOLD). Ver 9.2.2.1 DO NOT CONTAMINATE RIVERS, LAKES AND PONDS WITH THIS PRODUCT, WITH EMPTY CONTAINERS OR PACKAGING (envases o empaques). Ver 9.2.2.2 WARRANTY NOTICE: Ver 9.2.2.3/5.4.19 COUNTRY AND REGISTRATION NUMBER: Ver 9.2.2.4/5.4.17.2 BATCH NUMBER: (Established by the formulator) Ver 9.2.2.5/5.4.17.3.1 DATE OF FORMULATION: (Established by the formulator) Ver 9.2.2.6/5.4.17.3.2 by the formulator) Ver 9.2.2.7/5.4.17.3.
Toxicological band colour according to numeral 6 and table B.3 of ANNEX B, of this regulation.
3-PIECE LABEL FORMAT FOR RELATED SUBSTANCES, ADJUVANTS (COADYUVANTES) AND PHYSICAL VEHICLES (VEHÍCULO FÍSICO) LEFT PIECE CENTRAL PIECE RIGHT PIECE USE PRECAUTIONS AND WARNINGS:
Ver 9.3.1.1/ 5.4.15 DO NOT STORE THIS PRODUCT IN DWELLING HOUSES.
KEEP LOCKED UP OUT OF THE REACH OF CHILDREN, PERSONS WITH MENTAL DISABILITIES, ANIMALS, FOOD AND MEDICINES.
USE THE FOLLOWING PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT, DURING THE PREPARATION OF THE MIXTURE, LOADING AND APPLICATION: RUBBER GLOVES AND BOOTS, FACE MASK, HAT, EYE PROTECTION, LONG-SLEEVED PANTS AND SHIRT AND WATERPROOF APRON (if additional or specific equipment is required, the registrant must indicate it, according to the product's characteristics).
DO NOT EAT, SMOKE OR DRINK DURING THE HANDLING OF THIS PRODUCT.
BATHE AFTER WORKING AND PUT ON CLEAN CLOTHES see 5.4.15.
IN CASE OF POISONING, TRANSPORT THE PATIENT TO THE NEAREST DOCTOR OR HEALTH CENTRE AND PROVIDE THE LABEL AND THE PAMPHLET. Ver 9.3.1.3/5.4.14.1 SYMPTOMS OF POISONING: Indicate the characteristic symptoms of the poisoning, see 9.3.1.4/5.4.14.3 FIRST AID IN CASE OF INGESTION: IN CASE OF CONTACT WITH SKIN: IN CASE OF INHALATION: IN CASE OF CONTACT WITH EYES, See 9.3.1.5/ 5.1.14 and 5.4.16.1.
NEVER GIVE ANYTHING TO DRINK NOR INDUCE VOMITING TO UNCONSCIOUS PERSONS, See 9.3.1.6/5.4.16.2 literal a.
MEDICAL TREATMENT See 9.3.1.6/5.4.16.2 literal b.
STORAGE AND TRANSPORT: indicate the hazards, storage and transport conditions for the product 9.3.1.7, as defined in the numerals See. 8.1.13 and 8.1.14.
COMPANY LOGO See 9.3.2.1 /5.1.8 TRADE NAME, CONCENTRATION - FORMULATION See 9.3.1.2/ 3.16 / 5.4.1 CLASS -GROUP OR CHEMICAL FAMILY See 9.3.1.3/ 3.1, 3.28, 5.4.2 and 5.4.2.1, for adjuvants (coadyuvantes), indicate only the adjuvant class.
COMMON NAME OF THE ACTIVE INGREDIENT(S) OR COMPONENT(S) See 9.3.1.4/ 3.20 / 5.4.3, for adjuvants (coadyuvantes) indicate only the common name of the component.
Chemical composition %w/v or %w/w See 9.3.1.5/5.4.4. literal Chemical name of the active ingredient(s) or Components.............................. .............00.00 Concentration .........................................00.00 Solvent: (Declare hydrocarbon-based solvents when they are present.).
Contains: . amount of active ingredient or components for adjuvants (coadyuvantes). See 9.3.2.6/5.4.7 DENSITY: (liquids) See 9.3.2.7/ 5.4.5 Net content: (grams, kilograms, milliliters, liters, according to SI) See 9.3.2.8 / 5.4.8 PICTOGRAM ACCORDING TO TOXICOLOGICAL CLASSIFICATION AND CATEGORY AND SIGNAL WORD See 9.3.1.4 numeral 6 and Table B.2 of, ANNEX B ANTIDOTE:
See 9.3.1.5/ 5.4.14.2.
FORMULATOR: See 9.3.2.11/ 5.4.17.1 FOLLOW THE RECOMMENDATIONS GIVEN ON THE LABEL AND THE PAMPHLET. PROTECT THE ENVIRONMENT WITH GOOD AGRICULTURAL PRACTICES. See 9.3.3.1 DO NOT CONTAMINATE RIVERS, LAKES AND PONDS WITH THIS PRODUCT OR WITH EMPTY CONTAINERS OR PACKAGING. See 9.3.3.2 MANAGEMENT OF THE PRODUCT ONCE USED: Indicate the procedure for eliminating waste and disposal of empty containers and packaging. See 9.3.3.3 RECOMMENDED APPLICATION EQUIPMENT: See 9.3.3.4 AGRONOMIC USE: See 9.3.3.5 FORM OF PREPARATION OF THE MIXTURE: (except physical carriers) CROPS AND PESTS TO CONTROL: (except adjuvants (coadyuvantes)) DOSE: (per hectare / manzana) DOSAGE: (in the case of fumigants) INSTRUCTIONS FOR USE AND APPLICATION METHODS: (for physical carriers: distribution and method of placing the product on the crop, field and controlled environment as the case may be and number of units per hectare) TIMING AND FREQUENCY OF APPLICATION (except adjuvants (coadyuvantes)) RE-ENTRY INTERVAL TO THE TREATED AREA: (except adjuvants (coadyuvantes)) PRE-HARVEST INTERVAL: (interval between the last application and harvest) PHYTOTOXICITY: See 9.3.3.6 COMPATIBILITY: See 9.3.3.7 WARRANTY NOTICE: See 9.3.3.8/5.4.18 IMPORTER: See 9.3.9/11.37 COUNTRY AND REGISTRATION NUMBER See 9.3.3.10/5.4.17.2 BATCH NUMBER: See 9.3.3.11/5.4.17.3.1 FORMULATION DATE: See 9.3.3.12/ 5.4.17.2