International Pesticide Product Registration Requirements

Chapter 17

Pesticides Registration Process in Mexico 1

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J.P. Serres , J. Morgado , and G. Salas

Downloaded by AUBURN UNIV on November 15, 2016 | http://pubs.acs.org Publication Date: June 16, 1999 | doi: 10.1021/bk-1999-0724.ch017

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Marketing, R & D Department, and R & D Department—Registrations, Novartis Agro, S.A. DE C.V., Mexico City, Mexico

The registration of pesticides in Mexico is a long and complex process that involves many regulating institutions from different Ministries, such as, Agriculture, Health, Ecology and Commerce.

To commercialize pesticides in Mexico, each supplier needs to have a legal presence. The first step is to be audited by an approved technician and have available the following documentation required by the different Ministries. See Table I.

Table L Company Permits Ministry

Activities To Be Registered

1. Agriculture (SAGAR) Company Registration according to the: (NOM-033-FITO-1995) (NOM-034-FITO-1995)

Manufacturer Formulator Importer Distributor

2. Health (SSA) Federal sanitary license 3 Ecology (SEMARNAP) License to operate as a formulator

© 1999 A m e r i c a n C h e m i c a l Society

Garner et al.; International Pesticide Product Registration Requirements ACS Symposium Series; American Chemical Society: Washington, DC, 1999.

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140 To obtain the above mentioned permits, a company must meet a series of specific requirements established in different Mexican laws, norms and procedures.


Metrology and Standardization Federal Law. It is under the responsibility of the Commerce Ministry through the Standardization Department and the National Committee of Standardization to promote and coordinate the metrology and standardization activities among the different departments and entities of the Public Administration (7). Health Law. It is under the responsibility of the Health Ministry through the Department of Health and Labor Environment and the National Committee of Standards & Regulation and Sanitarian Protection to regulate matters on fertilizers, pesticides and toxic substances (2). Federal Law On Crop Protection. It is under the responsibility of the Agriculture Ministry through the Crop Protection Department and the National Phytosanitary Council to promote and to watch over the fulfillment of the phytosanitary resolutions as well as the development of activities and phytosanitary services (3). Mexican Official Standard. NOM-034-FTTO-1995. It establishes the phytosanitary requirements and specifications to manufacture, formulate, toll formulate, formulate and/or toll manufacture, and import of agricultural pesticides (4). Mexican Official Standard. NOM-033-FITO-1995. It establishes the phytosanitary requirements and specifications to commercialize agricultural pesticides (5). When this documentation is obtained, a company can continue with the registration process of every single product (active ingredient and its formulations). In Mexico, ajoint Commission, CICOPLAFEST - Interministerial (Commerce, Agriculture, Ecology, and Health) Committee for the control of the process and use of pesticides, fertilizers and toxic substances, is constituted to control the registration process and, therefore, the use of pesticides, fertilizers, and toxic substances. Table II provides the name of the ministries and their functions. This Commission has established 7 different types of registrations, according to the class of products involved: • • • • • • •

Plant Protection Products Animal Health Products Pesticides for Forestry Turf and Ornamentals Non-cultivated Area Products Domestic Pesticide (indoor) Active Ingredients


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Table Π. CICOPLAFEST Organization Actual Members Functions SAGAR - Agriculture Use and recommendation of pesticides Ministry SSA - Health Ministry Toxicological information label of pesticides SECOFI - Commerce Norms publication Ministry SEMARNAP - Ecology Ecological information Ministry New Participants by the end of 1998 ST - Labor Ministry Workers' safety on pesticide handling SCT - Communication and Regulation of pesticide transportation Transportation Ministry

CICOPLAFEST Objectives. The objectives of CICOPLAFEST are: • To coordinate regulation activities and control of pesticides, fertilizers and toxic substances. • To establish procedures for the analysis and further resolution regarding the registration and authorization related to the manufacturing, formulation, transportation, final disposal of left over, containers and packaging, of pesticides. • To issue registrations and import authorizations in accordance to the established program. CICOPLAFEST Organization. CICOPLAFEST is composed of the following: • A Technical Committee: Integrated by the directors of each Government Ministry mentioned above. • A Sub- Committee: Integrated by personnel responsible for the analysis and revision of the information and documentation submitted with each application for registration. • A Reception and follow - up area: Informs end user on status of the process for every single application. This process involves a lot of paper work, this is inevitable, and it is caused by the number of forms to be filled out.


142 Information Provided. The required technical, toxicological, ecological and safety information for product registration is submitted to CICOPLAFEST, which is the organization that controls the process of registration of pesticides in Mexico, to be registered as an industrial product. Table III summarizes the information to be provided for the review of a pesticide application.


Table ΙΠ. Required Information and Length of Time for Review. Content 1. Registration Dossier • Toxicological and environmental studies

Timing

3 to 6 months

Safety (handling of product): => If the product is a technical material, necessary worker and community warning statements must be indicated on the label in case of explosion or leakage. => If the product is a ready formulation, necessary product application precautions must be indicated, also in text labels • Country of origin documentation

1 month

2. Biological Data

18 months

• Analysis and further approval of the report of the field trials : Field trials must be performed in Mexico and have to be validated by a certified inspector who ensures that the trials have been properly conducted according to procedures established in the norms (β). These studies must fulfill the requirements established in the official Mexican norm NOM-032-FITO-1995 which indicates the phytosanitary specifications for the development of biological efficacy studies with pesticides and its technical resolution. When the active ingredient or the formulated product is new, an experimental evaluation permit must be obtained and local field trials must be conducted in different locations for biological efficacy, using different crops, and must include several rates of application.

12 months


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Table m. (Continued) 3. Registration Questionnaire: • Although most of the documents are accepted in the English language, this document is in the Spanish language. This is a kind of summary of the complete studies included in the dossier.

1 week

4. Label text:

2 days

• The contents of the company label text must comply with official Mexican Norm (7) and use recommendations only can be included along with efficacy field trials. NOM-045SSA1-1993. This is the case for products that include the following uses: agricultural, forestry, animal health, and gardening. 5. Registration application form: • This form contains the general information. The following documents should be attached: the sanitary license, the company registration as manufacturer and formulator, the printed label of the country of origin, the registration certificate for use in country of origin (in Spanish).

1 day

Registration Procedure When all the documents have been submitted to the authorities, CICOPLAFEST is then responsible for the analysis and further decision regarding the Application for the registration. This process takes from 3 to 4 months to be completed. When it is finally approved, it is then submitted for signature to the heads of SEMARNAP (Ecology Ministry), SAGAR (Agriculture) and SSA (Health), this process takes other 3 months. Usually, if it is not approved, additional information is required and the whole process is then repeated. Follow-up is essential to complete the registration of products since, once the registration package has been turned in, the waiting period varies from 17-18 months.


144 When the dossier information is obtained, the following steps and timelines, as delineated in Table IV, are followed to complete the registration process:

Table IV. Submission Elements and Length of Time for Review. Activity


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Submission of application form and dossier information

Timing 1 day

• Review and analysis of the information submitted by the Technical 5-6 Months Subcommittee. The Subcommittee decides if the petition is approved, denied or keeps pending.. If the status is pending, a company must complete any additional information/documentation required. • Submission of additional information. Missing information is 1 Month submitted for review and analysis by the Subcommittee which will issue the final approval. • Registration approval

1 Month

• The certificate of registration is issued by the Ministry of Health

2 Months

• The registration document has to be signed by the Directors of Crop 2 weeks Protection (DGSU-SAGAR), Health (DGSA-SSA), and Ecology (INE-SEMARNAP).

Literature Cited 1. SECOFI. 1992. Federal Law of Metrology and Standardization. Published in the Federal Official Diary on July 1 . 1992. 2. SSA. 1994. Health Law. Published in the Federal Official Diary on February 7, 1984. 3. SAGAR. 1994. Federal Law on Crop Protection. Published in the Federal Official Diary on January on January 5, 1994. 4. SAGAR. 1996. Mexican Official Standard NOM-034-FITO-1995 Published in the Federal Official Diary on June 24, 1996. 5. SAGAR. 1996. Mexican Official Standard NOM-033-FITO-1995 Published in the Federal Official Diary on June 24, 1996. 6. SEMARNAP. 1998. Federal Law on Ecology and Environment Protection. Published in the Federal Official Diary on January 28, 1998. 7. SAGAR. 1995. Mexican Official Standard. NOM-032-FITO-1995. Published in the Federal Official Diary on December 9, 1996. 8. SSA. 1995. Mexican Official Standard NOM-045-SSA1-1993 Published in the Federal Official Diary on October 20, 1995. st


International Pesticide Product Registration Requirements

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