ChemRegs Newsletter – December 2022

Revision to the EU CLP Regulation

The European Commission has just (19 December) proposed a revision to the Regulation on classification, labelling and packaging of chemicals (CLP) that will introduce new hazard classes for endocrine disruptors and other harmful chemical substances, in order to better protect people and the environment from hazardous chemicals.

The revised Regulation will also clarify the rules on labelling and for chemicals sold online. This aims to facilitate business and the free movement of substances and mixtures at EU level.

This Regulation takes the form of a Commission Delegated Regulation and introduces new hazard classes under the CLP for endocrine disruptors, as well as for chemicals that do not break down in the environment and can accumulate in living organisms, or risk entering and spreading across the water cycle, including drinking water.

The new hazard classes are:

• Endocrine disruptors (ED) for human health or the environment
• Persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB)
• Persistent, mobile and toxic (PMT); very persistent and very mobile (vPvB)

The new hazard classes are the result of extensive scientific discussions and will provide easier access to information to all users of such chemicals, notably consumers, workers and businesses. They could also allow further action to address and mitigate the risks of substances and mixtures under other EU downstream legislation such as REACH.

Some of these hazards are already partially covered in other legislation: endocrine disruptors and PBT/vPvB (REACH/Plant Protection Products and Biocidal Products Regulation), whereas the PMT/vPvM hazards are new in EU legislation.

Substances and mixtures with endocrine disrupting properties pose a concern to public health and the environment. It has been proven that endocrine disruption can lead to certain disorders in humans, among others birth defects, developmental, reproductive or neurodevelopmental disorders, cancer, diabetes and obesity, and that those disorders have a high and increasing incidence in both children and adults. It has also been demonstrated that endocrine disrupting properties can negatively affect animal populations.

The level of evidence as regards endocrine disrupting properties may be of different scientific strength. It is therefore proposed to create two categories of endocrine disruptors: known or presumed endocrine disruptors (category 1) and suspected endocrine disruptors (category 2), both for human health and for the environment.

In addition, the legislative proposal amending the CLP Regulation caters for:

• Better and faster processes for all actors to inform on hazards of chemicals placed in the EU market.
• Improved communication of chemical hazards, including online, through simpler and clarified labelling and advertising requirements. Among those, the proposal sets up a minimal font size for labels of chemicals.
• The right for the Commission to develop classification proposals on potentially hazardous substances, in addition to Member States and industry. This will speed up the pace at which hazardous substances are identified.
• First ever specific rules for refillable chemical products, so consumers buy and use chemical products, such as home care chemicals, sold in bulk in a safe way.

The press release from Brussels states that while companies may need to invest to comply with the new rules, they will benefit from easier access to up-to-date information on chemicals hazards and from simplified labelling rules. SMEs in particular will benefit from the latter.

Next steps

The Commission proposal amending the CLP Regulation will now be subject to the approval of the European Parliament and Council as part of the ordinary legislative procedure.

The Commission Delegated Act introducing the new hazard classes is expected to enter into force early next year, after scrutiny by the European Parliament and Council. To ensure that suppliers of substances and mixtures have time to adapt to the new classification and labelling requirements, provisions on deferred application of the obligation to classify and label substances and mixtures in accordance with the new Regulation will be included.

The EU CLP is based on the United Nation Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS) and the EU is to chair a new UN informal working group to develop global criteria for the newly adopted hazard classes. However, there is no guarantee that the EU proposal will be accepted by all parties to the GHS and it is possible that the EU CLP and the UN GHS may deviate.

The proposal for the EU CLP revision can be viewed at https://environment.ec.europa.eu/publications/proposal-clp-revision_en

Impact in the UK

At this moment in time it is not known if the GB CLP Regulation will follow suit and adopt the new hazard classes.

The process of updating and amending the technical sections of the GB CLP Regulation is done using secondary legislation (regulations), which can include introducing new classification hazard classes, adopting new test methodologies or strengthening the labelling packaging requirements for certain hazardous mixtures, such as those for laundry detergent capsules or pods.

All secondary legislation will be subject to the agreement of Parliament before the regulations can enter into force. The process for secondary legislation can be found on Parliament’s website. Amending regulations are expected to follow the negative procedure.

Public consultations are advertised using the HSE’s GB CLP e-Bulletin (and you are encouraged to sign-up if you have not already done so).

Defra publishes response to consultation on extending submission deadlines for transitional UK REACH registrations

Last year, the Department for Environment, Food and Rural Affairs (Defra) committed to consulting on extending submission deadlines for UK REACH.

This is to allow time to develop an alternative model for transitional registration, and if the decision is made to proceed, to develop and pass the necessary legislation. It is also necessary to allow industry time to comply with any new arrangements.

Defra launched a public consultation on extending the current deadlines for transitional registrations, seeking views on:

• two options to extend the current deadlines for transitional registration
• extending the dates for the Agency (HSE) to carry out compliance checks on 20% of registration dossiers

The consultation closed on 1 September 2022.

Defra have now published the summary of responses and government response to the consultation on GOV.UK.

They are now bringing forward secondary legislation, subject to the consent of the Scottish and Welsh governments, to extend the UK REACH submission deadlines by 3 years in line with this government response.

MERRY CHRISTMAS AND A VERY HAPPY NEW YEAR!!

We would like to wish you all a very Happy Christmas and a peaceful New Year.

For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk