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In December, the EU adopted amendments to the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008), introducing new hazard classes for endocrine disruptors and other harmful chemical substances. 

The new hazard classes will provide easier access to information to all users of such chemicals and, will allow further action to address and mitigate the risks of substances and mixtures under other EU legislation, such as REACH. CLP applies to all manufacturers, importers and downstream users of substances or mixtures who place products on the EU market. 

Elements of the Amendment

Comprehensive identification and classification of chemical hazards

The amended CLP will:

• add new hazard classes for chemicals with the following properties:

• endocrine disrupting chemicals (EDs)

• persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB)

• persistent, mobile and toxic (PMT), or very persistent and very mobile (vPvM) properties

• allow the Commission to initiate and fund more harmonised classification and labelling dossiers

• require updates of notifications of classifications within a certain early stage deadline

• make available the reasons for diverging notified classifications as well as make available the names of notifiers

The new hazard classes will trigger updates to Safety Data Sheets (SDS) and label with EU Hazard Statements, Signal Words and Precautionary Statements. The revision proposes to:

• strengthen the minimum requirements for hazard communication by introducing obligatory formatting rules, such as minimum font size and colour, to increase the readability of labels

• sell chemicals in refillable containers

• introduce rules on digital labelling

• allow broader use of fold-out labels for chemicals traded in several EU countries

• provide derogations for chemicals sold to consumers in bulk

Addressing legal gaps and ambiguities of CLP provisions

In November of 2022, the Competent Authorities for REACH and CLP (CARACAL) clarified several outstanding issues. The amended CLP will:

• introduce a requirement that suppliers have to ensure that substances or mixtures, including those sold online via distance sales, meet the requirements of CLP and chemicals’ labelling information should be made available before products are placed on the market, regardless of the means of sale

• ensure that the providers of online marketplaces design and organise their online interfaces in a way that enables suppliers to comply with their obligations regarding product safety information under applicable Union law

• make sure that all relevant actors, including distributors placing chemicals on the market across borders or rebranding/relabelling mixtures, notify poison centres across the EU about the relevant information, where necessary

Next Steps

The Commission proposal amending the CLP Regulation is now subject to the approval of the European Parliament and Council as part of the ordinary legislative procedure. The Commission's Delegated Act is expected to enter into force early this year.

Generally, a CLP amendment (Adaptation to Technical Principle (ATP)) comes into force 12 - 18 months after publication which is usually 20 days after publication in the Official Journal, giving industry some time to adapt. 

Formulators of mixtures first need all new classification information on substances before they can update safety information for mixtures. Therefore, two distinct and successive transitional periods for substances and mixtures are needed. The delegated act sets out the following transitional measures:

• a 24-month transitional period for substances not yet on the market within the EU 

• a 60-month period for the reclassification of substances already on the market. 

• For mixtures, the transition period was proposed as 36 and 60 months respectively  

Significantly and controversially, these new hazard classes are not based on those used under the GHS, which means the EU's hazard approach will no longer align with GHS. The EU will chair a new UN informal working group to develop global criteria for the newly adopted hazard classes. 

With the added complexity of divergence from GHS, Yordas recommends companies (especially non-EU companies) urgently reach out for advice and help with re-classification, or help with SDS tracking and management. 

To learn more about how your classification might change or how a sustainable substitution assessment can help your business, get in touch with our HazCom team today. You can also visit our website to learn more about our HazCom regulatory services.

CLP Delegated Act: https://environment.ec.europa.eu/publications/clp-delegated-act_en