Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC

Official gazette publication:Official Journal of the European Communities, L 294, 30 November 1993
Publication Date:30 Nov 1993
EUR-Lex - 31993L0105 - EN

Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC

Official Journal L 294 , 30/11/1993 P. 0021 - 0028
Finnish special edition: Chapter 13 Volume 25 P. 0084
Swedish special edition: Chapter 13 Volume 25 P. 0084


COMMISSION DIRECTIVE 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 93/72/EEC (2), and in particular Article 12 thereof,

Whereas, in accordance with the provisions of Directive 67/548/EEC, any new substance placed on the market should be notified to the competent authorities of Member States by means of a notification containing certain information including a technical dossier; whereas Article 12 of the said Directive requires that specific provisions should be laid down concerning the technical dossiers for polymers;

Whereas it is necessary that the technical dossier contains a test package for polymers which would supply the information necessary to evalute their foreseeable risks for man and the environment;

Whereas it is appropriate in order to avoid unnecessary testing to group polymers into families and thereby to require testing only of representative members of a family; whereas such representative testing shall continue to assure a high level of protection;

Whereas for some high molecular weight polymers, it is scientifically justifiable and appropriate to define a reduced test package (RTP);

Whereas criteria need to be developed to define those polymers with high molecular weight for which a reduced test package is deemed to be sufficient;

Whereas those criteria must ensure a high level of protection for man and the environment while ensuring that industry will continue to have the incentive to invest in continuing development of new and better polymers;

Whereas considering the limited experience with notification of polymers and the incomplete knowledge of risks associated with those substances, the strict criteria for RTP polymers may need to be revised in the light of experience gained with such notifications made in accordance with the new specific requirements laid down in this Directive;

Whereas the measures set out in this Directive are in accordance with the opinion of the Committee set up under Article 29 of Directive 67/548/EEC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Annex to this Directive shall be inserted in Annex VII to Directive 67/548/EEC in the form of Annex VII D.

Article 2

1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 December 1993 and shall forthwith inform the Commission.

2. When Member States adopt these provisions, 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 the third day following its publication in the Official Journal of the European Communities.

Done at Brussels, 25 November 1993.

For the Commission

Yannis PALEOKRASSAS

Member of the Commission

(1) OJ No 196, 16. 8. 1967, p. 1.

(2) OJ No L 258, 16. 10. 1993, p. 29.

ANNEX

'ANNEX VII D

SPECIFIC PROVISIONS CONCERNING THE TECHNICAL DOSSIER ("BASE SET") CONTAINED IN THE NOTIFICATIONS REFERRED TO IN ARTICLE 12

A. For the purpose of this Annex

- "homopolymer" is a polymer consisting of only one kind of monomer unit,

- "copolymer" is a polymer consisting of more than one kind of monomer unit,

- "polymer for which a reduced test package is acceptable", "RTP polymer", is a polymer that satisfies the criteria laid down in C.2,

- "family of polymers" is a group of polymers (either homopolymers or copolymers) with different number-average molecular weights or different compositions resulting from different ratios of monomer units. The difference in the number-average molecular weight or in the composition is determined not by unintentional process-related fluctuations but by deliberate alterations to the process conditions, the process itself remaining the same,

- "Mn" is the number-average molecular weight,

- "M" is the molecular weight.

B. Family approach

To avoid unnecessary testing, the grouping of polymers into families shall be possible.

The concept consists of testing representative members of a family with:

- Mn variable for homopolymers, or

- composition variable with Mn approximately constant for copolymers, or

- for Mn > 1 000, Mn variable with composition approximately constant for...

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