Europe Regulatory News

Today, 19 September 2024, the European Commission adopted new measures under the REACH Regulation to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA-related substances, which are a par...

Today, 19 September 2024, the European Commission adopted new measures under the REACH Regulation to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA-related substances, which are a part of the wider group of entire group of per- and polyfluoroalkyl substances (PFAS). These chemicals are highly persistent in water and pose risks to human health and the environment.

Targeted Product Bans Under the PFHxA Restriction

The restriction targets products where risks are not adequately controlled, and bans the sale and use of PFHxA in:

• Consumer textiles such as raincoats

• Food packaging such as pizza boxes

• Consumer compounds such as waterproofing sprays

• Cosmetics such as skin care products

• Firefighting foam applications for training and testing

Other applications such as semiconductors, batteries and green hydrogen fuel cells are not affected by the restriction.

Background on PFAS Chemicals

Per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals", are a large group of synthetic chemicals known for their extreme resistance to degradation in the environment. Due to their unique water- and grease-resistant properties, PFAS have been widely used in various industrial processes and consumer products, including non-stick cookware, waterproof textiles, food packaging and firefighting foams.

However, their persistence means that they accumulate over time in the environment and in living organisms, contributing to widespread contamination of soil and water, including drinking water supplies. This has raised significant concerns about the long-term effects of PFAS on human health, including links to cancer, endocrine disruption and immune system effects.

Key Objectives

The move is part of the EU’s wider effort to reduce PFAS emissions, as PFHxA often replaces the previously banned perfluorooctanoic acid (PFOA). The measure is based on scientific evaluations by the European Chemicals Agency (ECHA) and has been approved by the European Parliament and the Council.

Implementation Timeline

The restriction will enter into force 20 days after its publication in the Official Journal, with transition periods ranging from 18 months to 5 years, depending on the specific use, to allow industry to switch to safer alternatives.

Future Steps

While the current restriction specifically targets PFHxA and related substances, it is separate from the broader EU initiative to address the risks posed by the entire group of per- and polyfluoroalkyl substances (PFAS). The broader PFAS ban is currently being evaluated by the ECHA. This potential ban stems from a 2023 proposal by five European governments - Germany, Denmark, the Netherlands, Sweden and Norway - calling for significant restrictions on all PFAS chemicals due to their persistent environmental and health risks.

In April 2023, the European Commission introduced three new hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. These new classifications aim to better protect human hea...

In April 2023, the European Commission introduced three new hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. These new classifications aim to better protect human health and the environment by addressing specific hazards that were not fully covered under the existing Regulation.

New Hazard Classes Defined

The new hazard classes are: 

- Endocrine Disrupting Properties: Affects hormones and can cause reproductive, developmental and neurodevelopmental problems in humans and wildlife.

- Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) Properties: These substances persist in the environment, accumulate in organisms and are not easily broken down.

- Persistent, Mobile, and Toxic (PMT) or very Persistent and very Mobile (vPvM) Properties: These chemicals are highly mobile and persistent in the environment, with long-term effects that are still difficult to predict.

These hazards were introduced into the CLP Regulation because they were not adequatly covered by existing classifications. However, they are not entirely new to the Regulation. Endocrine disrupting and persistent, bioaccumulative and toxic properties have already been assessed under other regulatory frameworks, such as the Substance of Very High Concern (SVHC) process of the REACH Regulation, as well as the Biocides Products Regulation (BPR) and the legislation on plant protection products regulations. However, mobility is a relatively new considerationin European legislation.

New Obligations for Companies

With the addition of these new hazard classes, companies must assess their substances and mixtures to determine if they meet the new classification criteria. If they do, the following actions are required:

- Inform the European Chemicals Agency (ECHA): Update REACH registration dossiers with the new classification information.

- Notify Classifications: If a substance or mixture was not previously classified but now meets the new criteria, companies must notify the Classification and Labelling Inventory on the ECHA website.

- Poison Centre Notifications: Companies must also submit new poison centre notifications for mixtures that meet the criteria of the new hazard classes.

- Revise Safety Data Sheets: Safety data sheets must be updated to reflect the new classification, ensuring that accurate safety information is passed along the supply chain.

The IUCLID software was updated to include the new hazard classes on 29 April 2024. Since then, companies have been able to submit dossiers to ECHA containing information related to these new classifications.

Compliance Deadlines

To help companies adapt, the ECHA has set transition periods for the application of the new classifications as follows: 

- New substances: Compliance required by 1 May 2025. 

- Existing substances: Compliance required by 1 November 2026. 

- New mixtures: Compliance required by 1 May 2026. 

- Existing mixtures: Compliance required by 1 May 2028.

Support and Guidance

ECHA is currently updating its guidance to incorporate the new hazard classes, which is expected to be published in autumn 2024. In the meantime. companies can refer to existing guidance, such as the EFSA-ECHA guidance for endocrine disruptors and the REACH guidelines for PBT/vPvB assessments. The ECHA website also provides detailed support material, including main obligations, to help companies prepare or update their notifications.

Ongoing CLP Revisions 

An update of the CLP Regulation is also underway to further clarify classification rules and improve hazard communication. These changes will improve poison centre notifications, harmonised classification proposals, and online sales rules.

The Federal Office for Food Safety has issued an important reminder regarding the amended Fertilizer Act 2021 (DMG 2021), which has been in effect since October 1, 2021. This amendment includes an imp...

The Federal Office for Food Safety has issued an important reminder regarding the amended Fertilizer Act 2021 (DMG 2021), which has been in effect since October 1, 2021. This amendment includes an important regulation on the time limit for the approval of fertilizers, soil improvers, growing media and plant additives. This Act specifically regulates the approval and marketing of fertilizers, soil improvers, growing media and plant additives within Austria.

Products approved for an unlimited period according to Section 9a of the Fertilizer Act 1994 must be re-approved or removed from the market by January 1, 2025.

Action Required: To continue marketing these products after the deadline, a new application for approval must be submitted.

Application Process: Applications for “Re-approval of previously approved fertilizer products according to Section 9a of the DMG 1994” should be submitted via the BAES homepage. Make sure to upload the previous admission letter under the “Other” category for procedural efficiency.

Fertilizer Approvals: Austria 2025 Regulation aims to ensure that all fertilizers, soil improvers, growing media, and plant additives meet current safety and quality standards. Stakeholders are urged to take prompt action to comply with the new requirements and avoid disruptions in the availability of their product.

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On September 5, 2024, a significant new rule went into effect in Poland concerning the application of several provisions of the Act governing "fertilisers and fertilisation". The Minister of Agricultu...

On September 5, 2024, a significant new rule went into effect in Poland concerning the application of several provisions of the Act governing "fertilisers and fertilisation". The Minister of Agriculture and Rural Development has released a rule that provides detailed instructions and outlines specific guidelines for evaluating fertilisers and plant growth enhancers that promote plant development.

Here are the key updates to the new regulation:

• Permissible Pollutants: The Regulation specifies the maximum permitted concentrations of several contaminants in fertilisers and plant growth enhancers, such as chromium, cadmium, arsenic, lead, mercury, nickel, and others.

• Testing and Authorization: The Regulation lists the companies that are authorised to test fertilisers and other plant cultivation tools used in plant culture, and the specific tests required to ensure that quality criteria are met.

• Animal By-Products: The Regulation also specifies requirements for the inclusion of animal by-products in fertilisers and regulates their use.

• Labelling Requirements: It mandates certain information, such as the manufacturing process, use guidelines, and quality standards, to be published on fertiliser labels.

• Impact Assessments: The regulation also demands studies of the potential effects of fertilizers on human, animal, and environmental health.

The Polish fertilizer regulations aim to ensure the safe and effective use of fertilizers while protecting health and the environment.

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On 10 September 2024, the European Chemicals Agency (ECHA) published a reminder to small and medium-sized enterprises (SMEs) to check their reported company size in the REACH-IT registration system. T...

On 10 September 2024, the European Chemicals Agency (ECHA) published a reminder to small and medium-sized enterprises (SMEs) to check their reported company size in the REACH-IT registration system. This is part of ECHA’s ongoing efforts to ensure accurate reporting and compliance in the registration of chemical substances.

Key Message for SMEs

ECHA emphasised that if a company’s size has been incorrectly reported during registration, it must inform the ECHA Helpdesk immediately to avoid extra charges. Companies that update their size information before the Agency starts its verification process will only be required to pay the difference in the registration fee, instead of an administrative fee of up to EUR 19,900.

Steps to Update Company Size

ECHA encourages SMEs to visit its website for detailed guidance on how to determine their correct company size and compile the necessary documentation. In addition, SMEs should upload relevant supporting documents, regularly check their REACH-IT accounts for updates and ensure that their registration and contact details are accurate.

The European Commission has that two substances, N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP), will be added to the Authorisation List (Annex XVII) of the REACH Regulation (Regulatio...

The European Commission has that two substances, N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP), will be added to the Authorisation List (Annex XVII) of the REACH Regulation (Regulation (EC) No 1907/2006) by a new Commission Regulation which will impose significant restrictions on their use. These measures aim to protect the health of workers by addressing the risks associated with exposure to these chemicals.

This Commission Regulation was notified to the World Trade Organization (WTO) on 30 July 2024 and the notification is open for comments for 60 days.

About the Substances

DMAC (CAS No 127-19-5) and NEP (CAS No 2687-91-4) are widely used solvents with various industrial applications, including the production of man-made fibres, films, coatings and chemicals. Both chemicals are classified as toxic to reproduction, based on developmental toxicity studies, making their exposure a particular concern for workers in industries where they are used. NEP is also widely used in cleaning agents, oil field operations and polymer processing.

Proposed Restrictions

The new Regulation imposes strict restrictions on the market availability and use of DMAC and NEP. Specifically, these substances cannot be placed on the market or used in concentrations equal to or greater than 0.3 % unless manufacturers update safety reports and ensure compliance with Derived No-Effect Levels (DNELs). The DNELs for DMAC have been set at 13 mg/m³ for long-term inhalation exposure and 1.8 mg/kg body weight per day for long-term dermal exposure. For NEP, the long-term inhalation DNEL is 4.0 mg/m³ and the dermal DNEL is 2.4 mg/kg body weight per day.

Exposure to DMAC and NEP above these DNELs poses significant risks to the health of workers due to their reprotoxic properties. Prolonged exposure may cause adverse developmental effects, particularly in relation to reproductive health.

Timeline for Compliance

To give industry sufficient time to implement these changes, the Regulation includes a transitional period. For most sectors, the restrictions will come into force 18 months after the Regulation is published in the Official Journal of the EU. However, for the man-made fibres sector, where DMAC is heavily used, the application of the restriction will be postponed for 48 months.

Reasons for the Regulation

The Regulation follows an extensive review process carried out by the European Chemicals Agency (ECHA). Both the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) concluded that current measures are not sufficient to reduce the health risks posed by DMAC and NEP. The RAC recommended the proposed DNELs, while the SEAC emphasised the socio-economic benefits of implementing the restriction. The European Commission’s decision also reflects these findings, ensuring that industry prioritises worker safety while adapting to the new requirements.

Conclusion

The inclusion of DMAC and NEP in the REACH Authorisation List is a significant step forward in protecting workers from exposure to harmful chemicals. The transitional periods built into the Regulation will give industry time to comply with the new safety standards, ultimately reducing health risks and ensuring safer working conditions across the EU. The proposed regulation is expected to be adopted in the first quarter of 2025, with the restrictions taking full effect in the following 18 to 48 months.

On 30 August 2024, the European Chemicals Agency (ECHA) launched a public consultation on proposals to identify six new chemicals as Substances of Very High Concern (SVHCs). The consultation is open u...

On 30 August 2024, the European Chemicals Agency (ECHA) launched a public consultation on proposals to identify six new chemicals as Substances of Very High Concern (SVHCs). The consultation is open until 14 October 2024 and stakeholders are invited to submit comments in particular on the identity of the substances, their use, potential alternatives, exposure risks and hazardous properties. This input will help ECHA determine whether these substances should be included in the Candidate List for possible inclusion in the Authorisation List.

Substances of Very High Concern

SVHCs are chemicals that cause serious and often irreversible effects on human health and the environment. Once identified, these substances are included the Candidate List, where they are evaluated for possible inclusion in the Authorisation List. Chemicals on the Authorisation List cannot be used without prior approval from the European Commission. As of June 2024, the Candidate List contains 241 entries, while the Authorisation List contains 59.

Proposed Substances for Inclusion in the Candidate List

The six substances proposed for inclusion in the Candidate List are persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), toxic for reproduction or endocrine disruptors. The substances are listed in the table below and further details can be found here.

Next Steps

If no significant objections or new information are raised during the consultation, these substances will be added directly to the Candidate List. However, if the comments reveal new information that challenges their identification as SVHCs, the proposals will be referred to ECHA’s Member State Committee (MSC) for further consideration.

The deadline for submitting comments is 14 October 2024. Stakeholders can contribute by providing data on the uses of the substances, exposure levels, alternatives and the risks they pose.