Commission Directive 94/37/EC of 22 July 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market

• Published date: 29 July 1994
• Subject Matter: Plant health legislation,Approximation of laws
• Official Gazette Publication: Official Journal of the European Communities, L 194, 29 July 1994

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31994L0037

Commission Directive 94/37/EC of 22 July 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market

Official Journal L 194 , 29/07/1994 P. 0065 - 0081
Finnish special edition: Chapter 3 Volume 59 P. 0204
Swedish special edition: Chapter 3 Volume 59 P. 0204

COMMISSION DIRECTIVE 94/37/EC of 22 July 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 93/71/EEC (2), and in particular Article 18 (2) thereof,

Whereas Annexes II and III to Directive 91/414/EEC lay down the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product;

Whereas it is necessary to indicate in Annexes II and III to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossier;

Whereas greater precision can now be given to the data requirements concerning the identity, physical and chemical properties and further on the active substance, provided for in sections 1, 2 and 3 of Part A of Annex II;

Whereas greater precision can now be given to the data requirements concerning the identity, physical, chemical and technical properties and other general information on the plant protection product, provided for in sections 1 to 4 of Part of Annex III;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 91/414/EEC is amended as follows:

1. In Part A of Annex II, the sections headed '1. Identity of the active substance', '2. Physical and chemical properties of the active substance' and '3. Further information on the active substance' are replaced by Annex I hereto;

2. In Part A of Annex III, the sections headed '1. Identity of the plant protection product', '2. Physical, chemical and technical properties of the plant protection product', '3. Data on application' and '4. Further information on the plant protection product' are replaced by Annex II hereto.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 July 1995. They shall immediately inform the Commission thereof.

When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 3

This Directive shall enter into force on 1 August 1994.

Done at Brussels, 22 July 1994.

For the Commission

René STEICHEN

Member of the Commission

(1) OJ No L 230, 19. 8. 1991, p. 1.

(2) OJ No L 221, 31. 8. 1993, p. 27.

ANNEX I

1. Identity of the active substance

The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances.

1.1. Applicant (name, address, etc.)

The name and address of the applicant (permanent Community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

Where, in addition, the applicant has an office, agent or representative in the Member State to which the application for inclusion in Annex I is submitted, and if different, in the Rapporteur Member State appointed by the Commission, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact.

1.2. Manufacturer (name, address, including location of plant)

The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substances in Annex I, there are changes in the location or number of manufacturers, the information required must again be notified to the Commission and the Member States.

1.3. Common name proposed or ISO-accepted, and synonyms

The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided.

1.4. Chemical name (IUPAC and CA nomenclature)

The Chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomenclature, must be provided.

1.5. Manufacturer's development code number(s)

Code numbers used to identify the active substance, and where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated.

1.6. CAS, EEC and CIPAC numbers (if available)

Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported.

1.7. Molecular and structural formula, molecular mass

The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided.

1.8. Method of manufacture (synthesis pathway) of the active substance

The method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized.

1.9. Specification of purity of the active substance in g/kg

The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.

Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.

1.10. Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg

The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereo-isomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided.

For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided:

- chemical name according to IUPAC and CA nomenclature,

- ISO common name or proposed common name if available,

- CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,

- molecular and structural formula,

- molecular mass, and

- maximum content in g/kg.

Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided:

- chemical name according to IUPAC and CA nomenclature,

- ISO common name or proposed common name if available,

- CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,

- molecular and structural formula,

- molecular mass, and

- maximum content in g/kg.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.

Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component.

The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and...