Directive 1999/45/EC of the European Parliament and of the Council (repealed)Show full title

PART A U.K. Information to be communicated in the request for confidentiality

Introductory notes U.K.

A.

Article 15 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality.

B.

To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have:

• the same dangerous constituents present in the same concentration range,

• the same classification and labelling,

• the same expected uses.

A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation.

C.

The alternative designation used on the label must be the same as that given under heading 2 ‘Composition/information on ingredients’ of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.

D.

In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised.

Request for confidentiality U.K.

In accordance with Article 15 the request for confidentiality must obligatorily contain the following information:

1.

Name and full address (including telephone number) of the person established in the Community who is responsible for placing the preparation on the market (manufacturer, importer or distributor).

2.

Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.

NB: Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as evidence that the provisional classification takes account of all existing pertinent information available on the properties of the substance.
CAS No	Einecs No	Chemical name according to international nomenclature and classification (Annex I to Council Directive 67/548/EEC or provisional classification)	Alternative designation
(a)
(b)
(c)

3.

Justification for confidentiality (probability — plausibility).

4.

Designation(s) or commercial name(s) of the preparation(s).

5.

Is the designation or commercial name the same for all the Community?

YES ☐

NO ☐

If no, specify the designation(s) or commercial name(s) used in the different Member States:

• [F1 Belgium:

• Czech Republic:

• Denmark:

• Germany:

• Estonia:

• Greece:

• Spain:

• France:

• Ireland:

• Italy:

• Cyprus:

• Latvia:

• Lithuania:

• Luxembourg:

• Hungary:

• Malta:

• Netherlands:

• Austria:

• Poland:

• Portugal:

• Slovenia:

• Slovakia:

• Finland:

• Sweden:

• United Kingdom:]

6.

Composition of the preparation(s) defined in point 2 of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

7.

Classification of the preparation(s) according to Article 6 of this Directive.

8.

Labelling of the preparation(s) according to Article 10 of this Directive.

9.

Intended uses for the preparation(s).

10.

Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

Textual Amendments

F1 Substituted by Council Directive 2004/66/EC of 26 April 2004 adapting Directives 1999/45/EC, 2002/83/EC, 2003/37/EC and 2003/59/EC of the European Parliament and of the Council and Council Directives 77/388/EEC, 91/414/EEC, 96/26/EC, 2003/48/EC and 2003/49/EC, in the fields of free movement of goods, freedom to provide services, agriculture, transport policy and taxation, by reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia.