ChemRegs Newsletter – January 2021

New UK Chemicals Regulations – Updates

On 31 December 2020, the vast majority of EU rules concerning substances and mixtures in products were cut and paste into Great Britain (GB) rules and then brought into GB law on 1 January 2021. Northern Ireland will continue to be subject to existing EU law.

This includes:

• Biocides – Authorisation of biocidal substances and products, this becomes the GB Biocidal Products Regulation (GB BPR).
• CLP – Classification, labelling and packaging of substances and chemicals, this becomes the GB Classification, Labelling and Packaging Regulation, known as GB CLP.
• PIC – Prior informed consent, this becomes GB PIC.
• PPP – Pesticides or Plant Protection Products, this retains the same name.
• REACH – Registration, evaluation, authorisation and restriction of chemicals, this becomes UK REACH.

Biocides

Similarities between EU BPR and GB BPR include:

• Active substance approvals/product authorisations – Existing active substance approvals and UK product authorisations are valid in GB. Companies will need to ensure they have a base in the UK and may need to submit supporting data or other information to HSE (that has previously been submitted to the European Chemicals Agency (ECHA)) within prescribed timescales. This will be the same information as was previously submitted as HSE can no longer access the EU databases and IT systems where this information was held. HSE will not charge additional fees for receiving this data/information, however they will continue to charge fees for evaluating it.
• Active substances that were already in the EU Review Programme on 31 December 2020 are intended to be included in the GB Review Programme. For an active substance to be evaluated under the GB Review Programme, companies will need to submit their full application to HSE within prescribed timescales.
• A GB version of the Article 95 List has been established and operates in the same way as the EU Article 95 List. Companies that were already on the EU list on 31 December 2020 are included in the GB list. To remain on the list, companies will need to submit supporting information to HSE within prescribed timescales. This will be the same information as was previously submitted to ECHA, e.g an active substance dossier or a letter of access. Companies submitting a letter of access will only be able to remain on the GB Article 95 List if the data owner(s) have submitted the relevant data to HSE within the prescribed timescales. All companies will also have to ensure they are established in the UK.
• The same data requirements that were used for EU BPR also apply to GB BPR, including UK specific national requirements. Companies can continue to use the same format for their applications as is used in the EU, the EEA and Switzerland. Where there is no GB-specific guidance, HSE will use relevant technical guidance for EU BPR, as the two sets of legislation are very similar, but decisions taken using this guidance will apply only in GB. Future decisions taken in the EU, the EEA and Switzerland will not automatically apply in GB.

Differences between EU BPR and GB BPR:

• GB will take all its own decisions and will no longer participate in any of the EU decision making or the work sharing between EU Member States, the EEA and Switzerland. GB will no longer have access to EU systems so cannot gain access to information previously submitted under those systems, unless publicly available, or share information in that way with EU Member States, the EEA and Switzerland.
• GB will have the right to take different decisions to the EU, the EEA and Switzerland and will develop its own Review Programme of existing active substances. GB will no longer be participating in the EU Review Programme but may take into account evaluations done by other regulators, including the EU, the EEA and Switzerland.
• For active substance approval in GB, companies will need to submit a stand-alone GB application. HSE cannot accept invitations to become the evaluating Competent Authority (eCA) for active substances on behalf of the EU, the EEA and Switzerland.
• Technical equivalence – Active substance approvals which have been granted under EU BPR prior to 1 January 2021 will be considered approved under GB BPR with the same terms and conditions/restrictions. Consequently, GB may still be able to rely on assessments of Technical Equivalence which have been undertaken by ECHA prior to 1 January 2021.
• For product authorisation in GB, companies will need to submit a stand-alone GB application (eg for a GB national authorisation or GB simplified authorisation).

Further information can be found in the HSE Biocides fact sheets (PDF) 

CLP

The GB CLP Regulation adopts the United Nations’ Globally Harmonized System of the classification and labelling of chemicals (GHS) in the same way as the EU CLP Regulation does. However, from 1 January 2021:

• HSE becomes the relevant GB CLP Agency overseeing GB CLP functions for substances and mixtures placed on the GB market.
• All existing EU harmonised classification and labelling in force on 31 December 2020, are retained in GB as GB mandatory classification and labelling (GB MCL)
• The classification and labelling of substances and mixtures placed on the GB market must comply with GB MCL where relevant. GB MCLs are listed in the GB mandatory classification and labelling list (.xlsx)
• The requirement to notify hazardous mixtures to poison centres and generate a unique formula identifier (UFI) code derives from Annex VIII of EU CLP. Annex VIII did not become mandatory in the EU until 1 January 2021, which was after the end of the transition period (31 December 2020).  This means that Annex VIII was not retained in GB CLP, therefore there is no requirement to generate UFIs under GB CLP. Even though there is no requirement to generate UFIs, GB importers and downstream users are encouraged to submit information about the hazardous mixtures that they place on the GB market to the UK poison centre (NPIS).

PIC

The new GB PIC regime is similar to the existing EU regime but the 2 regimes operate independently of each other and there are different procedures for notifying exports under GB PIC:

• The GB PIC regime is operated by the HSE as the PIC Designated National Authority (DNA).
• Companies must notify their intention to export PIC-listed chemicals to countries outside GB by completing a PIC export notification form.
• For some chemicals the explicit consent of the importing country is required before export can take place, and the GB PIC DNA will seek this consent on behalf of the exporter.
• There is also a requirement for both exporters and importers of PIC-listed chemicals to report their annual quantities to the DNA.

PPP

All relevant EU law in relation to the regulation of plant protection products has been retained in GB law and retains the same official titles:

• All existing active substance approvals, PPP authorisations and maximum residue levels (MRLs) continue to be valid in Great Britain.
• Existing PPP authorisations remain valid until their current expiry date.
• Active substance approvals due to expire before December 2023 have been extended for 3 years to allow time to plan and implement the GB review programme.
• Great Britain will set MRLs based on their own assessments but all existing (EU) MRLs remain valid until they are amended. Applicants will need to continue to meet any existing conditions under the new GB pesticide regime.
• MRLs in Great Britain and the EU may start to diverge over time, so businesses producing food for export or trading in food produce should consider the requirements in their target market.
• No further mutual recognition applications can be accepted under the GB PPP regime. Any ongoing evaluations will be continued to a GB only decision.
• HSE will no longer issue new applications for parallel trade permits in Great Britain. Existing parallel trade permits will continue until their current expiry date or until 31 December 2022, whichever is sooner.

REACH

The key principles of the EU REACH Regulation have been retained. However:

• EU REACH registrations held by GB-based businesses have been carried across directly into UK REACH, legally ‘grandfathering’ the registrations into the new regime.
• GB-based holders of existing EU REACH registrations need to complete the ‘grandfathering’ process by providing basic information to the HSE by 30 April 2021. Companies will need to submit this information using the UK REACH IT system, called ‘Comply with UK REACH’.
• GB-based companies that were downstream users or distributors prior to the end of the transition period, under EU REACH, now become importers under UK REACH and will need to ensure the substances they purchase are covered by a valid UK REACH registration. To do this, they must send the HSE a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU or EEA by 27 October 2021.
• A new registration must then be submitted to the HSE within 2, 4 or 6 years of 28 October 2021. Alternatively, GB downstream users can encourage their EU or EEA supplier to appoint a GB-based Only Representative (OR), or change their source to a GB registered supplier.
• The UK implementation of REACH retains the authorisation provisions in full.
• The latest amendments to REACH Annex II, which sets out the requirements for the compilation of safety data sheets (SDS), apply via Regulation (EU) 2020/878. However, as this regulation only applies from 1 January 2021, i.e after the end of the transition period, this means it does not form part of UK REACH. However, it is understood that HSE are unlikely to enforce against GB-based companies who use the new SDS format.

Full guidance can be obtained from the HSE website.

Other News

Extension of ADR Driver and DGSA Certificates

Due to the current situation related to the coronavirus (COVID-19), some ADR contracting parties came together to prepare a multilateral agreement to compensate for the cancellation of refresher training sessions for ADR drivers and Dangerous Goods Safety Advisers (DGSAs) in their countries.

Luxembourg initiated multilateral agreement M324 on 18 March 2020 to allow ADR drivers and DGSAs whose qualifications expired between 1 March 2020 and 1 November 2020 to remain valid until 30 November 2020. This was signed by the UK on 20 March 2020.

M324 expired on 1 December 2020.

At the end of October 2020, most countries that signed M324 acknowledged that it would remain difficult to organize refresher training sessions for the next few months. Therefore, after consultation amongst Contracting Parties, Ireland initiated a new multilateral agreement M330 with the same provisions as M324 but with a validity period extended until 31 March 2021, hoping that by then, the training sessions will have resumed normally. This was signed by the UK on 3 November 2020.

However, at the end of January 2021, training sessions in person still remain difficult to organize, particularly for driver training sessions. Therefore, Germany has just initiated a new multilateral agreement M333 to allow exceptional extension of validity for drivers training certificates until 1 October 2021 and a corresponding one, M334, for DGSAs. The UK is due to sign this in the next few days.

This means that ADR driver training certificates that were due to expire between 1 March 2020 and 1 September 2021 will remain valid until 30 September 2021. These certificates will be renewed for five years if the driver provides proof of participation in refresher training and passes the examination before 1 October 2021. The new period of validity will begin with the original date of expiry.

Likewise, all DGSA certificates that were due to expire between 1 March 2020 and 1 September 2021 will remain valid until 30 September 2021. The validity of these certificates will be extended from the date of their original date of expiry for five years if the holders have passed the DGSA examination before 1 October 2021.

ADR 2021

The online version of the 2021 edition of ADR has been published on the UNECE website. It is available for free download from the following link:

https://unece.org/transportdangerous-goods/adr-2021-files [unece.org]

It is now known as the “Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)”  as the word “European” has been removed from the title.

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 2021.