ANNEX
| a 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 8 of Regulation (EU) No 528/2012. 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. | ||||||
| b For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm | ||||||
| c 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). | ||||||
| d 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). | ||||||
| Common Name | IUPAC NameIdentification Numbers | Minimum degree of purity of the active substancea | Date of approval | Expiry date of approval | Product type | Specific conditionsb |
|---|---|---|---|---|---|---|
| Octanoic acid | IUPAC Name: n-Octanoic acid EC No: 204-677-5 CAS No: 124-07-2 | 993 g/kg | 1 September 2015 | 31 August 2025 | 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: (1) For industrial or 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. (2) 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 Councilc or Regulation (EC) No 396/2005 of the European Parliament and of the Councild shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (3) Biocidal products containing octanoic acid 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, unless the Commission has established specific limits on the migration of octanoic acid into food or it has been established pursuant to that Regulation that such limits are not necessary. |
| 18 | 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: (1) Authorisations of products for non-professional use are subject to the packaging being designed to minimise user exposure, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means. (2) 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 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. | |||||