Europe Regulatory News

On 7 February 2024, the European Chemicals Agency (ECHA) launched a consultation on the potential recommendation of five substances for inclusion in the Authorisation List (Annex XIV of REACH). ECHA i...

On 7 February 2024, the European Chemicals Agency (ECHA) launched a consultation on the potential recommendation of five substances for inclusion in the Authorisation List (Annex XIV of REACH). ECHA is also seeking comments on the potential implications of adding a new hazard to dibutyl phthalate (DBP), an existing substance on the Authorisation List.

ECHA is particularly interested in gathering information on the uses of the five substances within the scope of authorisation, potential exemptions from the authorisation requirement, and the structure and complexity of the supply chains.

In addition, the European Commission is seeking information on the possible socio-economic impact of adding these substances to the Authorisation List. It is important to note that this information will be sent directly to the European Commission and will not be considered by ECHA.

The consultations is open until 7 May 2024.

The five proposed substances

The five substances under consideration are:

The identification of melamine as a substance of very high concern, is currently the subject of legal challenges before the General Court of Justice. Despite the ongoing legal actions, ECHA is proceeding with its recommendation and the outcome of the cases will be assessed after their conclusion.

Bis(2-ethylhexyl) tetrabromophthalate (TBPH) is part of an investigation on flame retardants requested by the European Commission. A call for evidence on this issue is open until 5 April. Given the uncertainty regarding the initiation of a REACH restriction process for TBPH and its potential uses, it remains in the draft recommendation for potential inclusion in the REACH Authorisation List. A final decision will be taken at a later stage.

More information on the substances in the consultation can be found here.

Key facts about dibutyl phthalate

Dibutyl phthalate (DBP) is used as a plasticiser in resins and polymers such as polyvinyl chloride (PVC). DBP was added to the Authorisation List in February 20211. The history of DBP as a substance of very high concern (SVHC) is as follows:

• 2008: DBP was identified as an SVHC for its reproduce toxicity properties and included in the Candidate List of SVHCs.

• 2011: DBP was added to Annex XIV of REACH (the Authorisation List), making it subject to authorisation.

• 2017: DBP was additionally identified as an SVHC due to its endocrine disrupting properties for human health.

• 202: The endocrine disrupting properties were added to Annex XIV.

• 2023: In December, DBP was again identified as an SVHC, this time for its endocrine disrupting properties to the environment.

Due to the recent identification of DBP as endocrine disrupting for the environment, ECHA has prepared a draft recommendation to amend the Annex XIV entry for DBP. The consultation on this draft aims to gather relevant information, in particular from stakeholders affected by the change in authorisation requirements due to the inclusion of the additional intrinsic property of DBP, which is already prioritised and included in the Authorisation List.

Background information

ECHA regularly recommends substances from the Candidate List for inclusion in the Authorisation List by the Commission. This time it has prioritised five substances from the Candidate List of substances of very high concern following the approach agreed with the Member States.

ECHA's draft recommendation is based on an assessment of registration data, available information, and initial discussions with the Member State Committee. The Member State Committee will formulate an opinion based on the feedback received during the consultation and ECHA will submit its final recommendation to the European Commission in spring 2025. The Commission will ultimately decide which substances will be included in the Authorization List and set the conditions for each substance. If a substance is included, it cannot be placed on the market or used after a certain date without a specific authorisation. Companies involved in the use, manufacture, or import of these substances can apply for authorisation.

The European Commission issued Commission Delegated Directive (EU) 2024/232 on 25 October 2023, amending Directive 2011/65/EU of the European Parliament and of the Council. This amendment ensures a ba...

The European Commission issued Commission Delegated Directive (EU) 2024/232 on 25 October 2023, amending Directive 2011/65/EU of the European Parliament and of the Council. This amendment ensures a balance between environmental sustainability and consumer safety by recognizing the benefits of using recovered PVC in specific electrical and electronic applications. The Directive will enter into force on 30 January 2024 and Member States shall apply the provisions from 1 August 2024. 

This amendment introduces an exemption for cadmium and lead in plastic profiles used in electrical and electronic windows and doors containing recovered rigid polyvinyl chloride (PVC). The exemption is based on a comprehensive technical and scientific assessment, including stakeholder consultations as required by Article 5(7) of Directive 2011/65/EU. 

Key Points of the Amendment: 

• Background: Directive 2011/65/EU restricts the use of hazardous substances listed in Annex II in electrical and electronic equipment, including cadmium and lead. The restriction does not apply to applications listed in Annexes III and IV. 

• Exemption Request: An application for an exemption for cadmium and lead in electrical and electronic windows and doors containing recovered PVC was submitted on 14 December 2015. 

• Evaluation: A thorough technical and scientific assessment study was conducted to evaluate the requested exemption, taking into account the environmental, health, and consumer safety impacts. 

• Scope: The exemption applies to electrical and electronic equipment falling under category 11 of Annex I to Directive 2011/65/EU (other electrical and electronic equipment). 

• Environmental Considerations: The use of recovered PVC, despite containing lead and cadmium, is considered preferable due to its lower energy and natural resource requirements compared to virgin PVC. The exemption is in line with the principles of environmental and health protection. 

• Limited Scope and Expiry Date: The exemption does not weaken the protection provided by Regulation (EC) No 1907/2006. The scope is in line with the relevant regulations, and the exemption will expire on 28 May 2028. 

Specific details outlined in the newly added Annex III to Directive 2011/65/EU. 

ANNEX III - Entry 46: Cadmium and Lead in Plastic Profiles 

‘Cadmium and lead in plastic profiles containing mixtures produced from polyvinyl chloride waste (hereinafter referred to as “recovered rigid PVC”), used for electrical and electronic windows and doors, where the concentration in the recovered rigid PVC material does not exceed 0,1 % cadmium by weight and 1,5 % lead by weight. 

From 28 May 2026, rigid PVC recovered from electrical and electronic windows and doors shall only be used for the production of new articles under the categories specified in entry 63, points 18(a) to (d) of Annex XVII to Regulation (EC) No 1907/2006. 

Suppliers of PVC articles containing recovered rigid PVC with a concentration of lead equal to or greater than 0,1 % by weight of the PVC material shall ensure, before placing those articles on the market, that they are visibly, legibly and indelibly marked with the statement: “Contains ≥ 0,1 % lead”. Where the marking cannot be provided on the article due to the nature of the article, it shall be on the packaging of the article. 

Suppliers of PVC articles containing recovered rigid PVC shall submit to national enforcement authorities upon request documentary evidence to substantiate the claims on the recovered origin of the PVC in those articles. Certificates issued by schemes to provide proof of traceability and recycled content, such as those developed according to EN 15343:2007 or equivalent recognised standards, may be used to substantiate such claims for PVC articles produced in the Union. Claims made on the recovered origin of the PVC in imported articles shall be accompanied by a certificate that provides equivalent proof of traceability and recycled content, issued by an independent third party. 

Applies to category 11 and expires on 28 May 2028.’ 

This detailed entry specifies the conditions, restrictions, and obligations related to the use of recovered rigid PVC in electrical and electronic windows and doors. Please ensure compliance with the requirements outlined to effectively navigate this regulatory landscape effectively. 

For further details and a complete overview of the amended Directive, please refer to Commission Delegated Directive (EU) 2024/232.  

On 5 February 2024, the European Chemicals Agency (ECHA) released a new updated version of the International Uniform Chemical Information Database (IUCLID) (v7.12.4). The new version includes various ...

On 5 February 2024, the European Chemicals Agency (ECHA) released a new updated version of the International Uniform Chemical Information Database (IUCLID) (v7.12.4). The new version includes various fixes and improvements, such as the update of the candidate substance list used for SCIP (Substances of Concern In articles as such or complex objects (Products)) submissions.

This latest release is particularly relevant for IUCLID users involved in compiling dossiers related to EU SCIP, Poison Centre notifications, and CLP notifications. It also incorporates the most recent improvements required for the preparation of the EU BPR Summary of Product Characteristics, which will enter into force on the 10 February 2024.

All users will also experience the benefits of the most recent modifications to the report generator. For ECHA Cloud Services users, automatic upgrades of their IUCLID instances will start this week.

The release notes for Version 7.12.4 can be accessed here.

The Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals adapted the new classification for ammonium hydrogendifluor...

The Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals adapted the new classification for ammonium hydrogendifluoride (CAS: 1341-49-7 Index No. 009-009-00-4) at the sixty-third session of Transport of Dangerous Goods. Sweden proposed the amendment to the classification.  

The Sub-Committee of Experts on the Transport of Dangerous Goods (SCETDG) further clarified that 

1. In addition to the harmonised classification skin corrosion 1B – H314, acute toxicity 3 – H 301 will be added to the classification. 

2. For the solid form it is listed as UN 1727 ammonium hydrogendifluoride and classified as Class 8 (corrosive) with no subsidiary hazards.  

3. For the liquid form there is already a 6.1 subsidiary hazard listed under UN 2817. 

4. The 24th edition of the Model Regulations, which will come into force in January 2027, will include the Class 6.1 (toxic) classification as a secondary hazard for UN 1727. 

Further details of the classification can be found here.

On 30 January 2024, the European Chemicals Agency (ECHA) launched its latest feature, ECHA CHEM, a user-friendly platform for sharing information on chemicals. The first release, which can be accessed...

On 30 January 2024, the European Chemicals Agency (ECHA) launched its latest feature, ECHA CHEM, a user-friendly platform for sharing information on chemicals. The first release, which can be accessed here, includes data from all REACH registrations and aims to provide accessible information to the public.

ECHA is known for maintaining the largest chemicals database in the EU, combining data submitted by industry with regulatory information. ECHA CHEM is designed to make the growing amount of information hosted by the Agency more accessible.

First release and future plans

The first version of ECHA CHEM contains information from over 100,000 REACH registrations submitted by companies to ECHA. Plans are in place to expand the database later this year to include the redesigned Classification and Labelling Inventory, followed by the launch of the first set of regulatory lists.

Previous chemical platforms

ECHA's previous Information on Chemicals platform, launched in 2016, grew rapidly and now contains information on more than 360,000 chemicals. In 2022, ECHA announced the development of a new system for publishing data on chemicals, with ECHA CHEM reflecting the Agency's commitment to efficiently manage the growing amount of data while embracing technological advances.

Insights from ECHA

Commenting on the significance of the launch, Mercedes Viñas, ECHA’s Director of Submissions and Interaction, stated, "ECHA CHEM is a significant step forward in enhancing our service for sharing data on chemicals gathered through ECHA’s current activities. It makes the information available online within a stable system and in a user-friendly manner."

Kai Taka-aho, Director of Information Systems, highlighted the flexibility of the platform, saying, "ECHA CHEM has been designed to be a flexible technical platform capable of handling large amounts of data, and adjustable for different needs. With the technological choices made, ECHA CHEM is a future-proof solution".

On 5 January 2024, the European Commission took a significant step to improve the regulatory landscape by adopting a Delegated Regulation (2024/197) for an adaptation to technical progress within Regu...

On 5 January 2024, the European Commission took a significant step to improve the regulatory landscape by adopting a Delegated Regulation (2024/197) for an adaptation to technical progress within Regulation (EC) 1272/2008. This regulation, commonly known as the CLP Regulation, deals specifically with the classification, labelling, and packaging of substances and mixtures. The regulation came into force on 25 January 2024.

The main objective of the Delegated Regulation is to make important updates to Table 3 of Part 3 of Annex VI to the CLP Regulation, which contains the list of harmonised classification and labelling (CLH) of hazardous substances. The proposed changes include the introduction of 28 new entries and the revision of 24 existing entries. The complete list is available here. The scientific assessment of these substances has been carried out in collaboration between the European Chemicals Agency (ECHA), its Committee for Risk Assessment (RAC) and the Member States authorities for decision-making at the Commission.

This proposed updates demonstrates the European Commission's commitment to keeping abreast of scientific and technical progress. The updates will play a crucial role in streamlining the harmonised classification and labelling processes and promoting consistency across the European Union. Manufacturers, importers, and downstream users are urged to stay informed about these proposed changes, as the new classifications will apply from 1 September 2025.

Harmonised classification and labelling

Manufacturers, importers, or downstream users are required to (self-)classify and label hazardous substances and mixtures in order to ensure a high level of protection for human health and the environment.

For substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) and respiratory sensitisers classification and labelling should be harmonised across the EU to guarantee appropriate risk management. This is achieved through harmonised classification and labelling (CLH).

The harmonised classifications are listed in Annex VI to the Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation. All manufacturers, importers, and downstream users of such substances should apply the harmonised classifications.

Proposals for CLH can be made for substances not currently listed in Annex VI to CLP. For substances with an existing harmonised classification changes may be made due to new information, scientific or technical developments, changes in classification criteria or re-evaluation of existing data.

On 23 January 2024, the European Chemicals Agency (ECHA) announced that 5 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) due to their hazardous properties. T...

On 23 January 2024, the European Chemicals Agency (ECHA) announced that 5 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) due to their hazardous properties. This means that the Candidate List now contains 240 entries. In addition, the existing list entry for dibutyl phthalate has been updated by ECHA to include its endocrine disrupting properties to the environment.

Substances of Very High Concern

Substances of Very High Concern (SVHCs) are substances that may cause serious and often irreversible effects on human health and the environment. A substance identified as an SVHC will be added to the Candidate List for possible inclusion in the Authorisation List. Some of the entries in the Candidate list are groups of chemicals, so the total number of impacted chemicals is higher. The Authorisation List has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants an authorisation for continued use.

Legal obligations for substances in the Candidate List

Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation there are legal obligations for substances included in the Candidate List.

• Suppliers must inform their customers and consumers if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs.

• Suppliers of Candidate List substances, either on their own or in mixtures, must provide a safety data sheet (SDS)to their customers.

• Importers and manufacturers of articles containing a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

In addition, under the Waste Framework Directive, companies must notify ECHA if the articles they produce contain SVHCs in concentrations above 0.1 % (weight by weight). This notification is then made publicly available in ECHA's Substances of Concern in Products (SCIP) database.

New substances in the Candidate List

The uses of the five new Candidate List entries include inks and toners, adhesives and sealants as well as washing and cleaning products. The substances are persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or toxic for reproduction. The new entries (and the updated entry) added on 23 January 2024 are listed below.