EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
Article 1 of Regulation (EU) 2019/1021 (‘the POPs Regulation’) establishes as the objective of that Regulation to protect human health and the environment from Persistent Organic Pollutants (‘POPs’) by prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the market and use of substances subject to the Stockholm Convention on POPs.
Hexachlorobenzene (HCB) is listed in Annex I to the POPs Regulation without an Unintentional Trace Contaminant (UTC) limit value. HCB was mainly used in the EU as pesticide. At the time of the listing in the POPs Regulation in 2004, it was considered that no limit value was needed because it was not expected to find HCB in substances, mixtures or articles except in pesticides. An inquiry was recently made to the European Chemicals Agency (ECHA) concerning a limit value for the presence of HCB as an impurity in substances. HCB is also known to be formed as a by-product during the manufacture of other chemicals (mainly chlorinated solvents) and pesticides, and in the waste streams of chloralkali plants and wood-preserving processes. From REACH registration dossiers, it is moreover known that the main use of substances containing HCB as a constituent or impurity relate to use in inks, coatings, paints and toners, use in wood application, in textile application and in plastics.
The lack of a specified UTC limit value results in legal uncertainty since stakeholders do not know whether a limit value applies nor which value. The absence of a harmonised limit value would be interpreted as if the limit of detection applies, which could be considered as a disproportionate restriction since it would prevent the placing on the market of any substance, mixture or article containing HCB. Article 4(1)(b) of the POPs Regulation sets out that the prohibition of the manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles, does not apply in the case of a substance present as an unintentional trace contaminant, as specified in the relevant entries of Annex I, in substances, mixtures or articles. The presence of HCB as UTC in substances, mixtures or articles should therefore be specified in Annex I.
In view of the currently available information, the setting of a limit value for the presence of HCB as UTC in substances, mixtures or articles is considered appropriate. Such UTC would clarify the legal situation and would facilitate harmonised enforcement throughout the Union.
Based on the available information, that limit value should be set at 10 mg/kg (0,001 % by weight) for the presence of HCB as UTC in substances, mixtures and articles.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
The draft delegated act was consulted with an expert group (the 'POP CA meeting') on 8 June and 23 November 2021 and comments were taken into account. The group is composed of all the relevant stakeholders - representatives of Member States, ECHA, the chemicals industry and the civil society.
A public consultation was carried out for the draft delegated act from x to x x 2021.
3.LEGAL ELEMENTS OF THE DELEGATED ACT
The delegated act amends the entry for hexachlorobenzene in Annex I to Regulation (EU) 2019/1021 in order to adapt it to scientific and technical progress. The legal basis for the proposed delegated act is Article 15(1) of Regulation (EU) 2019/1021.
COMMISSION DELEGATED REGULATION (EU) …/...
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amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants, as regards hexachlorobenzene
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,