Commission Implementing Regulation (EU) No 94/2014
of 31 January 2014
approving iodine, including polyvinylpyrrolidone iodine, as an existing active substance for use in biocidal products for product-types 1, 3, 4 and 22
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Iodine has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 1, human hygiene biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, and product-type 22, embalming and taxidermist fluids, as defined in Annex V to that Directive, which correspond respectively to product-types 1, 3, 4 and 22 as defined in Annex V to Regulation (EU) No 528/2012.
The data submitted for the purpose of the evaluation allowed conclusions to be also drawn on polyvinylpyrrolidone iodine.
Sweden was designated as Rapporteur Member State and submitted the competent authority report, together with recommendations, to the Commission on 20 April 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
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 13 December 2013, in an assessment report.
It appears from that report that biocidal products used for product-types 1, 3, 4 and 22 and containing iodine may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that the conditions specified in the Annex to this Regulation are satisfied.
It is therefore appropriate to approve iodine, including polyvinylpyrrolidone iodine, for use in biocidal products for product-type 1, 3, 4 and 22.
Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Iodine, including polyvinylpyrrolidone iodine, shall be approved as an active substance for use in biocidal products for product-types 1, 3, 4 and 22, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 January 2014.
For the Commission
The President
José Manuel Barroso
ANNEX
Common Name | IUPAC Name Identification Numbers | Minimum degree of purity of the active substance5 | Date of approval | Expiry date of approval | Product type | Specific conditions6 |
|---|---|---|---|---|---|---|
Iodine (including polyvinylpyrrolidone iodine) | IUPAC Name: Iodine EC No: 231-442-4 CAS No: 7553-56-2 IUPAC Name: Polyvinylpyrrolidone iodine EC No: n.a., CAS No: 25655-41-8 | 995 g/kg of iodine For polyvinylpyrrolidone iodine: the iodine content shall have a purity of 995 g/kg | 1 September 2015 | 31 August 2025 | 1 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. |
3 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. Authorisations are subject to the following conditions: For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council7 or Regulation (EC) No 396/2005 of the European Parliament and of the Council8 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. | |||||
4 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. Authorisations are subject to the following conditions:
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22 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not adressed in the Union level risk assessment of the active substance. Authorisations are subject to the following condition: For professional users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. |