ECHA launches public consultation on creosote
The European Chemicals Agency (ECHA) has launched a public consultation on a derogation from the exclusion criteria for creosote for product type 8 (TP 8; wood preservatives). Under the European Union (EU) Biocidal Products Regulation (BPR), active substances that meet the exclusion criteria can only be approved or renewed if they meet one or more of the following exemption criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal health or to the environment; or not approving the substance would have a disproportionate negative impact on society relative to the risks. Comments on whether the waiver conditions are met for creosote for PT 8 are due March 30, 2021.
Active substances meeting the following exclusion criteria are generally not approved or renewed under the BPR:
Carcinogenic, mutagenic and reprotoxic substances (CMR) of categories 1A or 1B according to the Regulation on Classification, Labeling and Packaging (CLP);
Persistent, bioaccumulative and toxic substances (PBT); and
Very persistent and very bioaccumulative substances (vPvB).
According to Opinion of the Biocidal Products Committee (BPC) on the application for renewal of approval, creosote in PT 8 is used as a wood preservative, as a fungicide and insecticide against wood rot fungi, against wood rot in contact with soil and water, and against insects. The BPC opinion states that creosote meets the exclusion criteria as it is classified under CLP as a category 1B carcinogen; it is proposed to classify it as toxic for reproduction category 1B; and it meets the criteria to be PBT and vPvB. Given that creosote meets the exclusion criteria, “the overall BPC conclusion is that the approval of creosote in product type 8 should not normally be renewed unless one of the waiver conditions of the 5(2) is fulfilled”.
As noted in our February 9, 2021 memo, “Post-Brexit, UK establishes new chemical regulatory regimesactive substances and biocidal products in Northern Ireland are still regulated by the EU BPR. A creosote derogation for PT 8 would allow its use in biocidal products in the EU, including Northern Ireland. A waiver approved in the EU will not apply in Great Britain (GB) under the GB BPR.
the Category TP 8 covers biocidal products “used for the preservation of wood, from and including the sawmill stage, or of wood products by the control of wood-destroying or disfiguring organisms, including insects.” It includes both preventive and curative products. The category was difficult under BPR. Many active substances have been submitted but never approved; seven of the 43 active substances that were or are currently authorized have expired, and creosote is one of nine substances currently under re-evaluation. Creosote is a substance of unknown or variable composition containing anthracene and polycyclic aromatic hydrocarbons, both considered non-threshold carcinogens; he meets more than one of the exclusion criteria and is therefore considered a candidate for substitution. The product faces an uphill battle to demonstrate that it meets one or more of the waiver criteria to renew its approval. The process of renewing an approval is complex and requires the submission of studies and data to demonstrate the safety of the product, despite meeting the exclusion criteria. Based on the studies and data submitted, BPC is of the opinion that the approval should not be renewed. With the protection of human health and the environment at the forefront, and suitable chemical and non-chemical alternatives available, it is likely that the product will not be approved for renewal.
©2022 Bergeson & Campbell, CPNational Law Review, Volume XI, Number 60