ChemRegs Newsletter – January 2023
Revision of GB Biocidal Products Regulation (BPR)
HSE are consulting on proposed revisions to Annexes II and III of the Great Britain Biocidal Products Regulation (GB BPR) (Regulation EU No 528/2012).
GB BPR applies to the supply and use of biocidal products. Biocidal products are products that control harmful organisms, and include insecticides, rodenticides, wood preservatives, anti-fouling coatings on ships, disinfectants, and hand sanitisers. Biocides are essential to society to protect human health and infrastructure but can also cause risks to human and animal health and the environment if used incorrectly. GB BPR therefore aims to ensure a high level of protection for both human and animal health and the environment.
Annexes II and III of GB BPR deal with the following:
Annex II – information requirements for biocidal active substances. The Annex details the information that must be submitted by applicants who wish to apply for a biocidal active substance to be approved.
Annex III – information requirements for biocidal products. This Annex details the information that must be submitted by applicants who wish to apply for biocidal products to be approved.
HSE is proposing to make technical updates to these Annexes which will:
- Introduce and place emphasis on In Vitro studies rather than In Vivo studies.
- Make new tests for endocrine disruptors part of the legal data requirements in GB BPR, rather than only being done on an ad hoc basis.
- Change mutagenicity requirements to reflect new information.
- Change requirements in relation to reproductive toxicity and generational studies.
- Change the requirements to include developmental neurotoxicity studies if certain triggers are met.
- Change the requirements to include efficacy data to support the innate activity of the active substance for the intended use.
The aim of the updates is to:
- keep up with technical and scientific progress
- adopt new testing methods
- encourage in vitro studies rather than in vivo animal studies
The changes are similar to updates made recently to data requirements in the European Union’s Biocidal Products Regulation (EU) No 528/2012. However, there are some minor differences which HSE believes will make the requirements more proportionate for GB needs.
HSE is seeking the views of interested parties on its proposed revisions to BPR Annexes II and III. The responses to this consultation exercise will be considered by HSE before the proposals are finalised.
The consultation is available via an online survey at https://consultations.hse.gov.uk/crd-biocides/rev-gb-bpr-annexes-ii-and-iii/consultation/subpage.2022-09-14.1581267654/
The consultation lasts for 8 weeks until 14 March 2023. A summary and analysis of responses will be published after the consultation has closed.
ADR 2023
The online version of the 2023 edition of ADR has been published on the UNECE website. It is available for free download from the following links:
Volume 1 English https://unece.org/sites/default/files/2023-01/ADR2023_Vol1e.pdf
Volume 2 English https://unece.org/sites/default/files/2023-01/ADR2023_Vol2e.pdf
Also available are the latest corrigendum and files with changes from previous version shown in revision (track changes) mode. The track changes versions of ADR are very useful in seeing at a glance what has been revised in ADR 2023.
Corrigendum 1 (applies to the French version) https://unece.org/sites/default/files/2022-12/ECE-TRANS-326c1f.pdf
Corrigendum 2 (applies to the English version) https://unece.org/sites/default/files/2022-12/ECE-TRANS-326c2e.pdf
Track version with changes in visible mode (new, modified and deleted text comparing to ADR 2021):
Track version Volume 1 English https://unece.org/sites/default/files/2023-01/ADR2023vol1e_track.pdf
Track version Volume 2 English https://unece.org/sites/default/files/2023-01/ADR2023vol2e_track.pdf
Multilateral Agreement re consignor exemption ADR 1.8.3.2.(b) / RID 1.8.3.2.(c)
The UK has initiated new Multilateral Agreements (MLAs) for ADR and RID.
ADR Multilateral Agreement M351 is made under section 1.5.1 of ADR, concerning the exemption from appointing a safety adviser for consignors – ADR 1.8.3.2 (b)
Multilateral Special Agreement RID 1/2023 is made under section 1.5.1 of RID, concerning the exemption from appointing a safety adviser for consignors – RID 1.8.3.2 (c)
Background
The UK submitted a paper (INF.7) at the recent RID/ADR/ADN Joint Meeting held in September 2022 to clarify whether the exemption within ADR 1.8.3.2 (b) and RID 1.8.3.2 (c) should apply to consignor only companies. The paper was adopted and the decision was made to include consignors in the exemption from ADR/RID in the next editions.
ADR 1.8.3.2 (b)/RID 1.8.3.2 (c) are amended as follows (amendments are underlined):
“1.8.3.2
The competent authorities of the Contracting Parties may provide that these requirements shall not apply to undertakings:
(a) ….
(b) The main or secondary activities of which are not the consignment, carriage or the related packing, filling, loading or unloading of dangerous goods but which occasionally engage in the national consignment, carriage or the related packing, filling, loading or unloading of dangerous goods posing little danger or risk of pollution.”
These changes will not appear in ADR and RID until the 2025 versions, as the publishing window for the 2023 versions had already passed when this proposal was submitted and adopted.
Until 2025, the DfT – as the UK Competent Authority – maintains the position that the exemption within ADR 1.8.3.2 (b) and RID 1.8.3.2 (c) does apply to consignor only companies. Please note in international carriage, Competent Authorities of other Contracting Parties may have a different interpretation of the relevant international dangerous goods regulations, including additional or different regulations through their own national legislation.
Therefore the DfT have initiated these MLAs to formalise this agreement with other signatories (provided they wish to sign up to the agreement).
They are available for download from:
M351 https://unece.org/sites/default/files/2023-01/M351e.pdf
The agreements can only be used once another country has co-signed and, once co-signed, the agreements are valid until 31 December 2024.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk