Commission Implementing Regulation (EU) 2016/105 of 27 January 2016 approving biphenyl-2-ol as an existing active substance for use in biocidal products for product-types 1, 2, 4, 6 and 13 (Text with EEA relevance)

Implementing Regulation (EU) 2016/105 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Biphenyl-2-ol is approved as an active substance for use in biocidal products for product-types 1, 2, 4, 6 and 13, 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 .

Supplementary provisions

ANNEXSupplementary provisions

ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Date of approval Expiry date of approval Product type Specific conditions Biphenyl-2-ol IUPAC Name: ortho-phenylphenol EC No: 201-993-5 CAS No: 90-43-7 995 g/kg 1 July 2017 30 June 2027 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. 2 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. The authorisations of biocidal products are subject to the following condition: For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. 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. The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for the surface water, sediment and soil compartments, biocidal products shall not be authorised for large scale disinfection, unless it can be demonstrated that risks can be reduced to an acceptable level. (3) 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 Council ( 2 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (4) Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council ( 4 ) , unless the Commission has established specific limits on the migration of biphenyl-2-ol into food or it has been established pursuant to that Regulation that such limits are not necessary. 6 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. The authorisations of biocidal products are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (2) In view of the risks identified for the aquatic compartment, biocidal products shall not be authorised for the preservation of washing and cleaning fluids and other detergents for professional use, unless it can be demonstrated that risks can be reduced to an acceptable level. 13 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. The authorisations of biocidal products are subject to the following condition: For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. ( 2 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ). ( 3 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ). ( 4 ) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC ( OJ L 338, 13.11.2004, p. 4 ).

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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