Commission Decision (EU) 2016/1796 of 7 July 2016 amending Decisions 2011/263/EU, 2011/264/EU, 2012/720/EU and 2012/721/EU in order to take account of developments in the classification of substances (notified under document C(2016) 4131) (Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel⁽¹⁾, and in particular Article 8(2) thereof,

After consulting the European Union Ecolabelling Board,

Whereas:

1. In accordance with Article 6(6) of Regulation (EC) No 66/2010, the EU Ecolabel may not be awarded to goods containing substances or preparations/mixtures meeting the criteria for classification as toxic, hazardous to the environment, carcinogenic, mutagenic or toxic for reproduction in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council⁽²⁾ or to goods containing substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council⁽³⁾.

2. In accordance with Article 6(7) of Regulation (EC) No 66/2010, for specific categories of goods containing those substances, where it is not technically feasible to substitute those goods as such or via the use of alternative materials or designs, or in the case of products which have a significantly higher overall environmental performance compared with other goods of the same category, the Commission may adopt measures to grant derogations from Article 6(6) of that Regulation.

3. Subtilisin is a hazardous substance with a harmonised classification according to Annex VI of Regulation (EC) No 1272/2008. This includes the following hazard classes: Respiratory sensitisation Category 1, Serious eye damage Category 1, Skin irritation Category 2 and Specific Target Organ Toxicity Single Exposure for respiratory tract Category 3.

4. Commission Decisions 2011/263/EU⁽⁴⁾ and 2011/264/EU⁽⁵⁾, as amended through Commission Decision 2012/49/EU⁽⁶⁾ include already a derogation for the enzyme subtilisin, classified as H400: Very toxic to aquatic life, for established ecological criteria for the award of the EU Ecolabel for detergents for dishwashers and laundry detergents, as subtilisin had been recognised as an important ingredient of these detergents and had been previously derogated. Moreover, with the same intention of allowing subtilisin in EU Ecolabel products, Commission Decisions 2012/720/EU⁽⁷⁾ and 2012/721/EU⁽⁸⁾ allowed enzymes classified as H400: Very toxic to aquatic life in for industrial and institutional automatic dishwasher detergents and industrial and institutional laundry detergents. Those derogations were granted recognizing the important function of subtilisin in the above mentioned detergent groups and its high level of degradation/inactivation in waste water treatment plants, and during detergents' use and transport to sewer systems. The derogations were needed because subtilisin was classified as Aquatic Acute 1 (M factor 1) (H400) by self-classification when it was registered under the Regulation (EC) No 1907/2006, which would have prevented its inclusion in products bearing the EU Ecolabel.

5. Regulation (EC) No 1272/2008 was amended by Commission Regulation (EU) No 286/2011⁽⁹⁾. The amendments to Regulation (EC) No 1272/2008 became applicable in respect of substances from 1 December 2012 and in respect of mixtures from 1 June 2015. Regulation (EU) No 286/2011 added new classification criteria for long-term aquatic hazard based on chronic aquatic toxicity and biodegradability data. On the basis of the new criteria, a recent study conducted by the REACH SIEF for subtilisin indicated that subtilisin has to be classified also as hazardous to the aquatic environment (chronic), Category 2. The substance is readily biodegradable and should not cause a risk to the environment because it is almost entirely deactivated in the sewage plants. As a result of this classification, subtilisin would be banned from the use in products bearing the EU Ecolabel. This would make it difficult for the established ecological criteria for the award of the EU Ecolabel for detergents for dishwashers, laundry detergents, industrial and institutional automatic dishwasher detergents, and industrial and institutional laundry detergents to correspond indicatively to the best 10-20 % of detergents and cleaning products available on the Union market in terms of environmental performance throughout their life-cycle.

6. Subtilisin enhances the cleaning performance of detergents by effectively breaking down proteinous stain components. The enzyme delivers excellent performance even at low temperatures with the required dosage that allows the respect of low temperature, compaction, and performance criteria under the EU Ecolabel scheme. At the moment, there is no alternative ingredient or technology. Other enzymes with different catalytic activities, e.g. alpha-amylase, lipase, pectate lyase can remove other types of deposits and stains, e.g. starch, fat and pectin stains, but they cannot remove proteinous stains.

7. The review of the criteria for the award of the EU Ecolabel for detergents for dishwashers and laundry detergents, set out in Decisions 2011/263/EU and 2011/264/EU, and the development of criteria for the award of the EU Ecolabel for industrial and institutional automatic dishwasher detergents and industrial and institutional laundry detergents and the related amendments did not take into account the new criteria for environmental classification introduced by Regulation (EU) No 286/2011.

8. This amendment shall apply retroactively from 1 December 2012, in order to ensure the continuity of the validity of the EU Ecolabel criteria for detergents for dishwashers, laundry detergents, industrial and institutional automatic dishwasher detergents, and industrial and institutional laundry detergents.

9. Commission Decisions 2011/263/EU, 2011/264/EU, 2012/720/EU and 2012/721/EU should therefore be amended accordingly.

10. The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION: