Regulatory Developments

ECHA Begins Public Consultation on Derogation to the Exclusion Criteria for Creosote

March 1, 2021

The European Chemicals Agency (ECHA) has begun a public consultation on a derogation to the exclusion criteria for creosote for product type 8 (PT 8; wood preservatives). Under the European Union (EU) Biocidal Products Regulation (BPR), active substances that meet the exclusion criteria can be approved or renewed only if they meet one or more of the following derogation criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal health or the environment; or not approving the substance would have a disproportionate negative impact on society compared to the risks. Comments on whether the conditions for derogation are met for creosote for PT 8 are due March 30, 2021.

Active substances meeting the following exclusion criteria are typically not approved or renewed under the BPR:

  • Carcinogens, mutagens, and reprotoxic (CMR) substances categories 1A or 1B according to the Classification, Labelling and Packaging (CLP) Regulation;
     
  • Endocrine disruptors;
     
  • Persistent, bioaccumulative, and toxic (PBT) substances; and
     
  • Very persistent and very bioaccumulative (vPvB) substances.
     

According to the Biocidal Products Committee (BPC) opinion on the application for renewal of the approval, creosote in PT 8 is used as a wood preservative, as a fungicide and insecticide against wood-rotting fungi, against wood rot in soil and water contact, and against insects. The BPC opinion states that creosote meets the exclusion criteria as it is classified under CLP as carcinogen category 1B; it is proposed to be classified as toxic for reproduction category 1B; and it meets the criteria for being PBT and vPvB. Since creosote meets the exclusion criteria, “the overall conclusion of the BPC is that the approval of creosote in product type 8 should normally not be renewed, unless one of the conditions for derogation in Article 5(2) is met.”

As reported in our February 9, 2021, memorandum, “Following Brexit, UK Establishes New Chemical Regulatory Regimes,” biocidal active substances and products in Northern Ireland are still regulated under the EU BPR. A derogation for creosote for PT 8 would allow it to be approved for use in biocidal products in the EU, including Northern Ireland. A derogation approved in the EU will not apply in Great Britain (GB) under the GB BPR.

Commentary

The PT 8 category covers biocidal products “Used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects.” It includes both preventive and curative products. The category has been a challenging one under BPR. Many active substances were submitted but never approved; seven of 43 active substances that were previously or are currently authorized have expired, and creosote is one of nine substances undergoing reevaluation at present. Creosote is a substance of unknown or variable composition containing anthracene and polycyclic aromatic hydrocarbons, both of which are considered to be non-threshold carcinogens; it meets more than one of the exclusion criteria and therefore is considered a candidate for substitution. The product faces an uphill battle to demonstrate that it meets one or more of the derogation criteria to renew its approval. The process of renewing an approval is a complex one and requires the submission of studies and data to demonstrate the product’s safety, in spite of meeting the exclusion criteria. Based on the submitted studies and data, BPC is of the opinion that approval should not be renewed. With the protection of human health and the environment in the foreground, and suitable chemical and non-chemical alternatives available, it is likely that the product will not be approved for renewal.


 
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