chemicals Archives - The Compliance People

Jurisdiction: Great Britain

Commencement: 31^st December 2023

Amends: Assimilated Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures
Mini Summary

The assimilated Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures introduces a globally harmonised system for classification, labelling and packaging of hazardous chemicals. Following the UK’s departure from the EU, this Regulation has been incorporated directly (with amendments) into domestic law in Great Britain. This entry describes the GB version of CLP.

Duties
Various duties apply.

Amendment

It is no longer a requirement to include the chemical’s unique formula identifier in the supplemental information section of a label.

The following amendments are revoked in response to the Retained EU Law (Revocation and Reform) Act 2023 (a previous update).

Regulation (EU) 2017/542 amending the CLP Regulation by adding an Annex on harmonised information relating to emergency health response.
Regulation (EU) 2020/11 amending the CLP Regulation as regards information relating to emergency health response.
Regulation (EU) 2020/1676 amending Article 25 of Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures as regards bespoke paints.
Regulation (EU) 2020/1677 amending Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures in order to improve the workability of information requirements related to emergency health response.

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Jurisdiction: United Kingdom

Commencement: 1^st November 2022

Amends:

GB Retained: Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;
GB Retained: Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals;
GB Retained: Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products;
Biocidal Product and Chemicals (Appointed of Authorities and Enforcement) Regulations 2013; and
The Health and Safety Nuclear (Fees) Regulations 2021.

Mini Summary

The GB Retained: Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures introduces a globally harmonised system for classification, labelling and packaging of hazardous chemicals. Following the UK’s departure from the EU, this Regulation has been incorporated directly (with amendments) into domestic law in Great Britain. This entry describes the GB version of CLP.

The GB Retained: Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals concerns the export and import of certain hazardous chemicals and pesticides and requires exporters to provide notification to importing countries and in some cases to obtain explicit consent from the importing country prior to the export. This EU Regulation has been retained into UK law.

The GB Retained: Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products details the rules for the authorisation of biocidal products placed on the market in Great Britain. Following the UK leaving the European Union (EU), this EU Regulation has been incorporated directly (with amendments) into domestic law in Great Britain (GB). This entry describes the GB version of the Biocides Regulation. There is a separate entry for the remaining EU version of the Regulation. (n.b. the EU version also applies in Northern Ireland).

The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 appoint the competent national authorities and enforcement authorities in Great Britain in relation to biocidal products (‘Biocides Regulation’), and labelling and packaging of substances and mixtures (‘CLP Regulation’). They also appoint the competent national authorities and enforcement authorities in both Great Britain and Northern Ireland in relation to export and import of hazardous substances (‘PIC Regulation’).

The Health and Safety and Nuclear (Fees) Regulations 2021 provide various set fees which the Health and Safety Executive can charge for regulatory functions, and also set out the power for the Executive to raise a “fee for intervention” where it finds an organisation in material breach of health and safety regulations.

Duties
Various duties apply.

Amendment

The following provisions are omitted.

Article 53a (Exercise of the delegation).
Article 53b (Urgency procedure).
Article 53c (Separate delegated acts for different delegated powers).

A minor technical change is made to replace a reference to the Commission with the Secretary of State. This allows the Secretary of State to adopt delegated acts.

Disclosure of information
The Health and Safety Executive (HSE) may disclose certain information concerning the trade in or safety of chemicals to ensure:

health and safety;
the protection of consumers; or
the protection of the environment.

Information shall not be disclosed if it would contravene data protection.

Persons may use the disclosed information for a permitted purpose, in accordance with regulation 3.

There are no changes to duties for organisations.

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Jurisdiction: Republic of Ireland

Commencement: 12^th May 2021

Amends: Safety, Health and Welfare at Work (Chemical Agents) Regulations 2001
Mini Summary

The Safety, Health and Welfare at Work (Chemical Agents) Regulations 2001 transpose Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. The Regulations also transpose the related Commission Directive 2000/39/EC establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC, through an approved Code of Practice.

The Regulations define activity involving chemical agents, biological limit value, chemical agent, hazard, hazardous chemical agent, health surveillance, occupational exposure limit value and risk.

The Regulations set down obligations on employers as regards:-

determination and assessment of the risk of hazardous chemical agents
prevention and control of exposure to hazardous chemical agents
specific protection and prevention measures
arrangements to deal with accidents, incidents and emergencies
information, training and consultation
health surveillance, including biological monitoring, and exposure records.

The Regulations also set out duties for employees and they provide for prohibitions and exemptions relating to the production, manufacture, or use at work of specified chemical agents

The regulations revoke and replace:

(SI 219/1988 European Communities (Protection of Workers) (Exposure to Lead) Regulations 1998
(SI 251/1989) European Communities (Protection of Workers) (Exposure to Chemical, Physical and Biological Agents) Regulations 1989
(SI 285/1991) Safety, Health and Welfare at Work Act, 1989 (Control of Specific Substances and Activities) Regulations 1991
(SI 445/1994) Safety, Health and Welfare at Work (Chemical Agents) Regulations 1994

Amendment

The Authority sets out the Codes of Practice* for work activities involving chemical agents, based on the relevant occupational exposure limit value.

*The Codes of Practice are written practical guidance, taking into consideration the legal requirements or prohibitions for work activities within industries.

The definition of ‘occupational exposure limit value’ is updated to mean the limit of the time-weighted average* of the concentration of a chemical agent within a worker’s breathing zone for a time period set out by the Codes of Practice.

*The time-weighed average is a worker’s daily exposure to hazardous substances which is calculated using the following:

an 8-hour work day or 40-hour work week;
the average levels of exposure to the hazardous substance; and
the time spent in that area.

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Jurisdiction: GB

Amends: Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as amended
Mini Summary
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) imposes requirements on manufacturers and importers of chemicals and restricts the use of certain high risk chemicals.

Amendment
The REACH Regulation requires registrants (i.e. those who have registered chemicals under REACH) to update their registrations with any relevant new information. However, no deadlines are provided within which updates must be submitted. Regulation (EU) 2020/1435 is an implementing Regulation which supplements REACH by setting out deadlines for updating of registrations. Where any of the following changes in circumstances apply, the registrations should be updated within the time frames summarised below:

Registrant’s identity: within 3 months of the change.
Composition of the substance registered: within 3 months of manufacture or import of the changed substance.
Tonnage band: where the quantity manufactured or imported changes, taking the registration into a higher tonnage band, within 3 months of the change (see Article 3 for additional detail).
Cessation of manufacture or import: within 3 months.
Identified new uses of the substance: within 3 months.
Advice against identified use: where new advice is identified against a known use, within 3 months.
New knowledge of risks to human health and/or the environment: within 3 months of the knowledge being identified.
Classification and labelling under ‘CLP’ (Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures): a change in classification or labelling of a substance due to it being in some way re-assessed should be submitted within 6 months. A change to the hazard classification or labelling categories of CLP (i.e. where the CLP Regulation itself is changed) which affects the substance, must be notified by no later than when the change takes effect.
Chemical safety report/ guidance in safe use: within 12 months of a change in either of these.
New testing required under Annexes IX and X: within 6 months of the registrant identifying that new testing is required for a substance, or 12 months if the testing is identified as necessary as part of a testing strategy for a group of substances.
Change in access granted: within 3 months of the change.
New testing required in relation to 1-6 & 8 above: if any of 1-6 & 8 above leads to a requirement to carry out further testing, the deadline for submission of the update is changed to 3 months from the receipt of the test report.
Combined updates: where any of the above circumstances applies and this also triggers the need to update or amend a chemical safety report or the guidance on safe use, the combined update should be submitted within 12 months from the date when the final test reports needed for the update have been received.
Joint submissions: where an update by a member of a joint submission is dependent on a lead registrant making a prior update, the deadline for the member to make the update is:
- 3 months if it relates to any of 1–8 or 11 above;
- 9 months if it relates to 9 or 12.

The deadline is from when the HSE informs the lead registrant that their update registration is complete.

Updates of Annexes to REACH
Where any of the Annexes to REACH is amended, resulting in a change of information required to be submitted in support of a registration, the registration must be updated by the date from which that amendment to the Annex applies.

Process for updating registrations
Registrations should be updated through the ECHA. Information for registrants can be found via the ECHA website.

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