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EU Persistent Organic Pollutants Regulation Updated

The European Commission has published an amendment to the persistent organic pollutants regulation to include hexabromocyclododecane


The European Commission has published two regulations: Commission Regulation 2016/293/EU and Commission Regulation 2016/460/EU amending Annexes I, IV and V of Commission Regulation 850/2004 on Persistent Organic Pollutants (POPs) to include hexabromocyclododecane (HBCDD).

Commission Regulation 2016/293/EU amends Annex I specifying the exemption for HBCDD expires on 26 November 2019 and Commission Regulation 2016/460/EU includes the proposed concentration limits for HBCDD in Annexes IV and V.

HBCDD is a brominated flame retardant, primarily used in polystyrene, which is now prohibited from being placed on the market, whether on its own or in preparations.

A threshold limit equal to or below 100 mg/kg (0.01 % by weight) has been set for HBCDD occurring as an unintentional trace contaminant in substances, preparations and articles. In order to take account of technical developments, this threshold limit should be reviewed by the Commission within 3 years from the date of entry into force of this regulation with a view to lowering the threshold.

An amendment has a specific exemption for the production and use of HBCDD in expanded polystyrene and extruded polystyrene in buildings. A material containing HBCDD must be identifiable by labelling or other means throughout its life cycle.

HBCDD is the latest in a series of brominated flame retardants to be prohibited under Regulation (EC) No 850/2004 and includes the polybrominated diphenyl ethers (PBDE) such as hexabromodiphenyl ether, heptabromodiphenyl ether, tetrabromodiphenyl ether and pentabromodiphenyl ether.

HBCDD has also recently been identified as a priority substance for inclusion in Annex II to Commission Directive 2011/65/EU restricting the use of certain hazardous substances in electrical and electronic equipment, as described in Commission Delegated Directive (EU) 2015/863.

There are currently no recognised methods but it is likely that CEN standards will be developed using similar methods and techniques described for PBDE in the EN 62321 ‘Determination of certain substances in electrotechnical products’ standards.

HBCDD, as well as being a cause for concern in the environment, has also been the subject of studies in food where the European Food safety Agency (EFSA) published a Scientific Opinion on Hexabromocyclododecanes (HBCDDs) in Food. The EFSA opinion provides information on different methods, recognising there are no official methods to determine HBCDD in food, describing techniques such as LC-MS/MS, GC/MS and GC-ECD. The scarcity of certified reference materials, which are essential to be able to validate methods to meet the requirements of EN ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories, is also noted.

Published 28 September 2016