Commission Directive 2012/16/EU of 10 May 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include hydrochloric acid as an active substance in Annex I thereto Text with EEA relevance

Published date11 May 2012
Subject MatterPlant health legislation
Official Gazette PublicationOfficial Journal of the European Union, L 124, 11 May 2012
L_2012124EN.01003601.xml
11.5.2012 EN Official Journal of the European Union L 124/36

COMMISSION DIRECTIVE 2012/16/EU

of 10 May 2012

amending Directive 98/8/EC of the European Parliament and of the Council to include hydrochloric acid as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

(1) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes hydrochloric acid.
(2) Pursuant to Regulation (EC) No 1451/2007, hydrochloric acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive.
(3) Latvia was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 16 October 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 9 December 2011, in an assessment report.
(5) It appears from the evaluations that biocidal products used as private area and public health area disinfectants and other biocidal products, in accordance with the said product-type 2, and containing hydrochloric acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include hydrochloric acid in Annex I to that Directive.
(6) Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable
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