Europe Regulatory News

On 9 February 2024, the European Commission announced a four-week consultation on a draft regulation aimed at strengthening the restriction of bisphenol A (BPA) in food contact materials (FCMs) and ar...

On 9 February 2024, the European Commission announced a four-week consultation on a draft regulation aimed at strengthening the restriction of bisphenol A (BPA) in food contact materials (FCMs) and articles. The proposed legislation also covers other bisphenols and bisphenol derivatives, with provisions for derogations and transition periods for businesses. Stakeholders and the public are invited to submit their comments on the proposed regulations by 8 March 2024.

Bisphenol A

The substance 4,4'-isopropylidenediphenol, commonly known as bisphenol A (BPA) (CAS number 80-05-7), is used in the production of certain food contact materials and articles. Its main applications include the manufacture of epoxy resins for varnishes and coatings on metal food packaging such as cans, tins, and jar lids. BPA is also found in certain types of plastic used in food storage and processing equipment. Its versatile chemical properties can extend its use to materials such as printing inks, adhesives, ion exchange resins, and rubbers in finished food contact articles. Concerns arise because BPA can migrate from the materials or articles it comes into contact with into food, exposing consumers to this substance.

The use of bisphenol A (BPA) in plastic food contact materials is authorised by EU Regulation 10/2011, with a specific migration limit of 0.05 mg/kg of food set by Regulation (EU) 2018/213. This limit is based on the opinion of the European Food Safety Authority (EFSA). The regulation also bans BPA in polycarbonate drinking cups or bottles for babies and young children. In addition, there is a ban on its use in varnishes or coatings for materials intended to come into contact with certain childcare articles, reinforcing the existing ban in Commission Regulation (EU) No 321/2011 on polycarbonate feeding bottles and cups for young children.

In 2023, the EFSA published an updated opinion on BPA, identifying adverse effects, including effects on the immune system, based on new scientific data.

Content of the draft regulation

Highlights of the draft regulation include:

If the draft Regulation is implemented the following transitional provisions will apply for final food contact articles:

1. Final food contact articles made of plastics, varnishes, coatings, inks, adhesives, ion exchange resins, and rubbers complying with pre-existing rules can be placed on the market until 18 months after the entry into force.

2. Certain articles (single-use for certain food types, varnished metal surface articles, and repeat-use articles in professional food production equipment) complying with pre-existing rules can be marketed until 36 months after entry into force.

Timeline

The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union. Upon entry into force Regulation (EU) 2018/213 will be repealed.

On 8 February 2024, negotiators from the European Parliament and the Council reached a provisional political agreement on the phasing out of dental amalgam. The agreement is in line with the European ...

On 8 February 2024, negotiators from the European Parliament and the Council reached a provisional political agreement on the phasing out of dental amalgam. The agreement is in line with the European Commission’s proposal to address the remaining uses of mercury in the European Union, with the overall goal of achieving a mercury-free environment in line with the EU's Zero Pollution Ambition to protect the health of EU citizens and the ecosystem.

About Mercury

Mercury, a highly toxic chemical, poses a significant threat to both human health and the environment. When released into the environment, it enters the food chain and accumulates in fish in particular. Exposure to high levels of mercury can lead to adverse effects on the brain, lungs, kidneys, and immune system.

Despite the availability of viable mercury-free alternatives, approximately 40 tonnes of mercury is still used annually for dental amalgam in the EU. This continued use is due to existing legislation that only prohibits the use of dental amalgam for treating teeth in children under 15 years old, as well as pregnant and breastfeeding women.

Key Points of the Agreement

1. Ban on dental amalgam: Dental amalgam, which contains mercury, will no longer be permitted for use in the EU starting from 1 January 2025, except where deemed strictly necessary for specific medical needs.

2. Derogation period: A derogation allowing the use of dental amalgam will be in place until 30 June 2026 for EU countries that have not adapted their reimbursement systems to cover alternatives. This is to avoid negative impacts on low-income individuals who may face socio-economic challenges as a result of the phase-out.

3. Export ban: The export of dental amalgam will be banned from 1 January 2025 and the manufacture and import into the EU will be banned from 1 July 2026.

Satisfaction of the rapporteur

Marlene Mortler, rapporteur from the European People's Party (EPP) in Germany, expressed her satisfaction with the agreement, stressing the importance of banning dental amalgam while ensuring excemptios for medically necessary cases. Mortler underlined the need to consider the socio-economic consequences and stressed the commitment to prevent the export of mercury-containing to non-EU countries.

Next Steps

The next steps include the adoption of the agreement by the European Parliament and the Council. Once adopted, the new law will be published in the EU’s Official Journal and will enter into force 20 days later.

On 7 February 2024, Members of the European Parliament (MEPs) approved new rules to minimise exposure to harmful substances in the workplace. The approved rules include updated exposure limits for lea...

On 7 February 2024, Members of the European Parliament (MEPs) approved new rules to minimise exposure to harmful substances in the workplace. The approved rules include updated exposure limits for lead, the first in four decades, and the introduction of the first-ever limits for diisocyanates.

In the European Union approximately 50,000 to 150,000 workers are exposed to lead each year and 4.2 million workers are exposed to diisocyanates. The recently approved rules legislation, aim to improve the protection of workers' health by reducing the exposure limits for these substances.

Lead and diisocyanates are widely used in building renovation, the manufacture of batteries and wind turbines, and to make electric vehicles lighter. The new exposure will protect those actively involved in the transition to greener practices.

Stricter Limits on Lead Exposure

The rules address the health effects of lead exposure which affects fertility, foetal development, and causes damage to the nervous system and kidneys.

Lead exposure limits were last updated in 1982. The new occupational exposure limit value for lead is set at 0.03 mg/m3, which is less than 25 % of the current value. A biological limit value of 15 µg/100 ml will also be established.

The European Commission will review these limit values within five years, paying particular attention to the protection of female workers of childbearing age, taking the latest scientific data into account.

First Exposure Limits for Diisocyanates

Diisocyanates, known to cause occupational asthma and allergic reactions, will now have occupational exposure limits. These are set at 6 µg NCO/m3 for an eight-hour working day and 12 µg NCO/m3 for short-term exposure. The European Commission plans to review these limits by 2029.

Protecting Workers with Past Exposure to Lead

Recognising the challenges posed by past exposure to lead, the legislation requires regular medical check-ups for workers with high blood lead levels. This proactive approach ensures their ongoing health and assesses their fitness to perform tasks involving lead exposure.

Next Steps: Council Endorsement and Publication

Formal adoption by the Council is the next step before the regulations can enter into force. The approved text will then be published in the EU Official Journal, marking a crucial step in the implementation of improved workplace safety measures.

On 30 January 2024, the European Chemicals Agency (ECHA) published its Strategy Statement for the years 2024-2028, emphasising its commitment to protecting human health and the environment through rob...

On 30 January 2024, the European Chemicals Agency (ECHA) published its Strategy Statement for the years 2024-2028, emphasising its commitment to protecting human health and the environment through robust chemical safety measures. Aligned with the EU’s goals on chemical safety, the strategy outlines key objectives to address challenges related to climate change, biodiversity loss, and pollution, while contributing to the EU’s broader green, digital, and sustainable growth agenda.

Expanding Legal Mandate and Policy Landscape

ECHA acknowledges a broadening legal mandate, influenced by the Chemicals Strategy for Sustainability and EU Green Deal initiatives. Despite policy changes, the agency remains dedicated to ensuring the protection of health, promoting the free circulation of substances in the internal market, and fostering competitiveness and innovation. Proactively preparing for new tasks and responsibilities, ECHA maintains a strong focus on transparency, independence, and the quality of scientific opinions and decisions. Additionally, efforts are directed towards supporting industries, especially Small and Medium-sized Enterprises (SMEs), in meeting their legal obligations.

Collaboration and Expertise

Dr. Sharon McGuinness, ECHA Executive Director, highlighted the importance of collaboration with the Commission, Member States, agencies, and stakeholders. The strategy underscores the Agency's role in advancing scientific knowledge and data to deliver chemical safety in the present and future. She stated, "I am happy to present our new Strategy Statement, which will drive ECHA’s direction and priorities for the next five years. Our new vision, chemical safety through science, collaboration and knowledge will guide us as we deliver our strategy and our values of integrity, transparency, collaboration and innovation will inform our actions. We look forward to working with our staff, partners and stakeholders in delivering our strategy.”

Paul Krajnik, Chair of ECHA’s Management Board, highlighted the significance of the updated strategy, stating, "The new ECHA Strategy reflects the broadening of our legal mandate in support of the European Union’s ambitious goals on chemical safety, and its commitment to the protection of health and the environment. This new strategy equips ECHA to continue its successful implementation of its agenda into the future."

Key Elements of ECHA's Strategy for 2024-2028:

1. Be a trusted chemicals agency: ECHA aims to strengthen its position as a reliable and trusted authority in the field of chemical safety, reinforcing confidence in its actions and decisions.

2. Respond to emerging challenges and changes in the legal landscape: The strategy underscores ECHA's commitment to addressing new challenges and adapting to changes in the legal landscape, ensuring a dynamic and effective response to evolving circumstances.

3. Communicate and engage: ECHA places a strong emphasis on transparent communication and active engagement with stakeholders, fostering a collaborative approach in its mission to protect health and the environment.

4. Lead on chemical knowledge and expertise: The agency aspires to take a leadership role in advancing chemical knowledge and expertise, contributing significantly to the scientific understanding of chemical safety.

5. Invest in people and organisational excellence: Recognizing the critical role of its workforce, ECHA plans to invest in the development of its personnel to ensure they are well-prepared for the challenges and tasks ahead, promoting organizational excellence.

With these strategic goals and priorities in place, ECHA is poised to make significant strides in chemical safety over the next five years, aligning its efforts with the broader objectives of the European Union. The agency looks forward to collaborative efforts with its staff, partners, and stakeholders to achieve its vision for a safer and more sustainable future.

The complete text of the Strategy Statement 2024-2028 can be found here.

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.