David Steinberg, Steinberg & Associates

Article 7a on Information Disclosure
The Seventh Amendment to the European Union (EU) Cosmetic Directive has a clause requiring certain information about cosmetics to be made available to the EU public. That clause, which addresses certain dangerous substances and also addresses animal testing, has not attracted much discussion or attention but has enormous implications for cosmetic companies.

The crucial paragraphs in Article 7a Part 1 subpart (h) refer to Sections (a) and (f) and now read as follows, in reference to: 

      … data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet legislative or regulatory requirements of non-member countries.

     Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States shall ensure that the information required under (a) and (f) shall be made easily accessible to the public by any appropriate means, including electronic means. The quantitative information required under (a) to be made accessible shall be limited to dangerous substances covered by Directive 67/548/EEC.

The purpose of Article 7a is to identify the information that must be made available to the competent authorities. This information also is known as a manufacturer’s product information package or, as some people call it, the product dossier. This also includes the information the manufacturer is required to give to consumers, if requested, about the product.