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Parliamentary questions
16 May 2018
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-001459/2018

Regulation (EU) No 528/2012(1) (‘BPR’) regulates products used to protect humans against harmful organisms. In Annex V to this regulation, biocidal product-types are described.

In product-type 1 is set out the description of disinfectants for human hygiene specifying that products in this group are used for human hygiene purposes, applied on or in contact with human skin for the primary purpose of disinfecting the skin. Pursuant to Article 3(3) of the BPR the Commission may decide, at the request of a Member State, whether a specific product is a biocidal product in order to ensure a harmonised situation in the Union.

The BPR does not apply to products that fall under the scope of Directive 2001/83/EC(2), which provides for the basic framework for the regulation of medicinal products for human use. The applicability of legislation to a product will depend, among others, on the intended purpose, composition, its presentation and claims made for the product concerned.

Contrary to the BPR, Directive 2001/83/EC does not provide for a mechanism to decide at the EU level whether a product is a human medicinal product. Only competent national authorities may decide, on a case-by-case basis, whether a product can be classified as a medicinal product. Therefore, as Union law stands, it is indeed possible that differences exist between Member States in the classification of products as medicinal products.

The Commission notes that regardless of the applicable legislation, any product needs to be authorised by the relevant competent authorities and it has to be proven to be safe and efficacious for the intended uses. Therefore, a high level of protection is ensured under the current legal situation.

(1)Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and the use of biocidal products, OJ L 167, 27.6.2012, p. 1.
(2)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67.

Last updated: 17 May 2018Legal notice