Article 15U.K.Confidentiality of chemical names

Where the person responsible for placing the preparation on the market can demonstrate that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as:

  • irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in point 2.3.4 of Article 10, or

  • harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 presenting acute lethal effects alone

will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Annex VI, be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned a Community exposure limit.

Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the competent authority of the Member State in which the preparation is to be first placed on the market.

This request must be made in accordance with the provisions of Annex VI and must provide the information required in the form in Part A of that Annex. The competent authority may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request.

The authority of the Member State receiving a request for confidentiality shall notify the applicant of its decision. The person responsible for placing the preparation on the market shall forward a copy of this decision to each of the Member States where he wishes to market the product.

Confidential information brought to the attention of the authorities of a Member State or of the Commission shall be treated in accordance with Article 19(4) of Directive 67/548/EEC.