The UK Publishes the REACH (Amendment) Regulations 2023

By Susana Planas MunGavin, BSc, MSc, regulatory specialist, Supply Chain team, UL Solutions

On July 19, 2023, the REACH (Amendment) Regulations 2023, SI 772 entered into force. They were made on June 28, 2023, by the Department for Environment, Food and Rural Affairs Health in order to amend Article 41 of the retained Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, hereinafter referred to as “the REACH Regulation.”

The functions and powers attributed to the Agency under the retained UK REACH Regulation have been assigned to the Safety Executive (HSE). Regulation 3 of the Amending Regulations of 2023 amend Article 41(5) of the REACH Regulation and extend the deadlines before which the HSE is required to carry out compliance checks on minimum percentages of certain types of registration dossiers. These include the following:

• until Oct. 27, 2027, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(a);
• until Oct. 27, 2030, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(b);
• until Oct. 27, 2035, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(c).

Deadlines applicable under Article 127P(4B) relating to the post-Implementation Period (IP) completion period for submitting the registration information to the HSE have been extended, therefore instead of regulating a period of days after the end of the IP on Dec. 12, 2020, the Regulations now identify specific dates for the information to be submitted. The HSE is the assigned Agency in the UK to assess and review information on registration of substances, pursuant to Articles 127B, 127L and 127M.

Any Great Britain-based legal entity intending to manufacture or import a substance into England, Scotland and Wales at or above 1 tonne per year is required to submit a registration to the HSE for that substance. As registration is not required for mixtures, it should be noted that the substances that comprise a mixture must be registered if the aggregated import volumes for any of those substances reach 1 tonne or more per year.

The deadlines that have been established for information submission include the following:

October 27, 2026:

(i) substances included on the candidate list by virtue of Article 59(1A) of REACH Regulation on or before Dec. 31, 2023;

(ii) substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1A or 1B, in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation) and manufactured in Great Britain or imported, in quantities reaching one tonne or more per year per manufacturer or importer, at least once after IP completion day;

(iii) substances classified as aquatic chronic category 1 (very toxic to aquatic life with long lasting effects) or aquatic acute category 1 (very toxic to aquatic life) in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation) and manufactured in Great Britain or imported, in quantities reaching 100 tonnes or more per year per manufacturer or importer, at least once after IP completion day;

(iv) substances manufactured in Great Britain or imported, in quantities reaching 1,000 tonnes or more per year per manufacturer or importer, at least once after IP completion day.

Oct. 27, 2028:

(i) substances added to the candidate list referred to in Article 59(1), other than by virtue of Article 59(1A), during the period beginning Jan. 1, 2024, and ending Oct. 27, 2026;

(ii) substances manufactured in Great Britain or imported, in quantities reaching 100 tonnes or more per year per manufacturer or importer, at least once after IP completion day.

Oct. 27, 2030: 

(i) in respect of substances manufactured in Great Britain or imported, in quantities reaching 1 tonne or more per year per manufacturer or importer, at least once after IP completion day.

Recommended action items

• Review the list of registered substances submitted to the HSE. 
• Ensure substance registration dossiers contain the required regulated information 
• Review whether registration has been submitted by Lead registrant in the case of GB-based companies that manufacture in or import substances into GB in quantities of 1 tonne or more per year.
• Review whether as a GB-based company that had submitted a registration dossier to ECHA via REACH-IT, a registration number prior to the date of Exit, i.e. Jan. 31, 2020, has been received.
• Review whether as a manufacturer, formulator or article producer based outside of GB, you have appointed a GB-based Only Representative (OR) to take on the registration responsibilities of the GB-based importers.

References

• HSE Registration
• The REACH (Amendment) Regulations 2023
• Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals