Europe Regulatory News

The revision of the FCM Regulation has been long-awaited, with the Regulation not having been reviewed since its entry into force in 2004. In May 2020, the Commission announced that it would adopt a p...

The revision of the FCM Regulation has been long-awaited, with the Regulation not having been reviewed since its entry into force in 2004. In May 2020, the Commission announced that it would adopt a proposal for the revision in the fourth quarter of 2022. However, due to the Regulation being “complex” the revision was postponed to 2023.

Recently the Commission's Department on Health & Food Safety (DG Sante) revealed that work on the revision would not begin until 2025. The Commission's numerous proposals announced under the REACH and CLP revisions have added to the challenges, with questions arising over the extent to which these policy options, including essential use criteria, should be factored into the work on updating the FCM Regulation.

Despite the delay in legislative work, DG Sante has outlined plans for 2023 to refine solutions and define more detailed policy options for the revision of the FCM Regulation. The focus will be on policy pillar A: 'shifting the focus onto the final material' and pillar B: 'prioritisation of substances'. Together, these pillars will form the core of the future risk management approach, with new material categories being applied.

The goals for pillar A are for producers of final FCMs to have full knowledge of 'migratables' and to become solely accountable for their release above the permitted safe levels. DG Sante's objective is also for all migratables to be risk assessed by national authorities or potentially businesses, as outlined in pillar B.

Under pillar B, the directorate will also create three tiers. The first is generic rules that will apply to the use of the most hazardous substances. Tier two will see public authorities conducting risk assessments, while the final tier envisages business operators assessing "more benign" chemicals.

In addition to these pillars, DG Sante plans to work on a study to assess the impact and options of pillar C – 'supporting safer and more sustainable alternatives'. The study is expected to be submitted to the Commission's regulatory scrutiny board by Q1 2024.

It has furthermore been pointed out that the drafting of the proposal is likely to clash with the European elections in May 2024 and the appointment of a new college of commissioners six months later. This could further delay the proposal, depending on other priorities such as dealing with the cost-of-living crisis and energy security.

If the proposal comes out in 2025, a revised regulation might not come into place until 2026 or 2027.

Starting from February 25th, certain perfluorocarboxylic acids (C9-C14 PFCAs), which are a subgroup of PFAS, will be restricted throughout the European Union. After this date, PFCAs cannot be used in ...

Starting from February 25th, certain perfluorocarboxylic acids (C9-C14 PFCAs), which are a subgroup of PFAS, will be restricted throughout the European Union. After this date, PFCAs cannot be used in most applications or placed on the market, although some uses have been granted longer transition periods. The aim of the restriction is to reduce or prevent exposure of people and the environment to PFCAs, while also avoiding the substitution of PFOA, which has been banned globally since July 2020. The EU's goal of phasing out all non-essential uses of PFAS under the Chemicals Strategy for Sustainability is being met with this measure.

The list of substances under restriction is available here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R1297

A comprehensive plan that outlines more than 150 steps to assist business and government agencies in achieving the Green Deal and digital targets by 2050 has been released by the European Commission i...

A comprehensive plan that outlines more than 150 steps to assist business and government agencies in achieving the Green Deal and digital targets by 2050 has been released by the European Commission in collaboration with stakeholders. The main elements of the EU Green Deal are: Climate action, Clean energy, Sustainable industry, Buildings and renovations, Sustainable mobility, Eliminating pollution, Farm to Fork, Preserving biodiversity, Research and development as well as Preventing unfair competition from carbon leakage. 

In order to support the Union's transition to a "toxic free" environment, climate neutrality, circular economy, and digitalization, the "Transition Pathway for the Chemical Industry" document, which was published on 27 January 2023, proposes steps, including safe and sustainable by design (SSbD) measures and substitution to safer substances. 

Sustainable competitiveness is one of its 2050 "building blocks." Developing, commercialising, deploying, and encouraging the use of SSbD substances and materials are some of the proposals made to achieve this. Other suggestions include making sure that dangerous chemicals that are prohibited in the EU are not produced for export, by amending applicable legislation as needed. 

A list of actions that stakeholders may do to encourage the transition to safer chemicals is also included in the document. As part of the new circular economy action plan, one phase is to adopt and enforce the Ecodesign for Sustainable Products Regulation (ESPR). To guarantee that consumer items don't include chemicals that cause cancer, gene mutations, disrupt the reproductive or endocrine systems, or are persistent, bioaccumulative, and hazardous, authorities should take action to expand the general approach to risk management. This suggests a new digital infrastructure where parties could share high quality data on chemical hazard profiles and the environmental impact of products. They could extend this to other chemicals, including those toxic to particular organs and those affecting the immune, neurological, or respiratory systems.

The European Chemicals Agency (ECHA) has released the full details of a proposed EU REACH restriction that aims to limit the use of more than 10,000 per- and polyfluoroalkyl substances (PFASs), which ...

The European Chemicals Agency (ECHA) has released the full details of a proposed EU REACH restriction that aims to limit the use of more than 10,000 per- and polyfluoroalkyl substances (PFASs), which are commonly known as "forever chemicals." The proposal has been authored by the authorities of five European countries - Denmark, Germany, the Netherlands, Norway, and Sweden - and outlines two options for restricting the use and placement on the market of these substances, which are concerning due to their persistence, bioaccumulation, and toxicity.

The first option involves a complete ban of PFAS with no exemptions and a transition period of 18 months after the regulation takes effect. Option two is a complete ban with specific, time-limited exemptions for certain uses, such as active substances in plant protection and biocidal products, as well as human and veterinary medicinal products. This option also carries an 18-month transition period and a 5 or 12-year exemption period, depending on the application. The authors of the restriction propose a ban on consumer products after 18 months, a 5-year exemption period for products where alternatives are being developed, and a 12-year exemption period for products where no alternatives exist at the moment.

The restriction report considers option two to be the most balanced approach, allowing time for alternatives to be developed while still promoting the phase-out of PFASs. The proposal is the broadest restriction of PFASs ever submitted, covering at least 10,000 of these substances.

The restrictions will not result in a total ban on PFASs in other substances, mixtures, or articles but will set limits for their use.

The next steps for the proposal include legal checks by ECHA's committees for socio-economic analysis and risk assessment, followed by a six-month consultation and adoption by the European Commission. The restriction is expected to be adopted and enter into force in 2025 and become applicable in 2026-2027.

The background:

In the EU, around 230,000 tonnes of PFASs are placed on the market each year, used in various sectors including textiles, food packaging, electronics, construction, and medical devices. Recently risks related to the manufacturing, placement, and use of PFASs has been identified. Thus a proposal to restrict per- and polyfluoroalkyl substances (PFASs) under the European Union's chemicals regulation, REACH, has been submitted to the European Chemicals Agency (ECHA) by the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden in January.

In relation to the EU's RoHS Directive, the European Commission stated on January 16, 2023, that it is looking for comments from interested parties on a request for an exemption for lead in polyvi...

In relation to the EU's RoHS Directive, the European Commission stated on January 16, 2023, that it is looking for comments from interested parties on a request for an exemption for lead in polyvinyl chloride (PVC). The specific exemption requested relates to lead in PVC, which is utilised as a base material in sensors, which are used in in-vitro diagnostic medical equipment. 

The Member States are required by Directive 2011/65/EU on the restriction of the use of certain hazardous chemicals in Electrical and Electronic Equipment (EEE) to assure that EEE put on the market does not include the hazardous compounds listed in Annex II to that Directive.  

Of the 10 compounds that are now listed, lead is one that is considered to be hazardous. The remaining ones are bis (2 ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate, cadmium, hexavalent chromium, mercury, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and polybrominated biphenyl (DIBP). The materials and electronic equipment parts that are exempt from the substance limits are listed in the Directive's Annexes III and IV for possible purposes. 

It has been shown that lead is a poisonous toxin that harms the neurological system's growth, causes chronic kidney illness, and raises blood pressure. In PVC, the foundation material for sensor cards, lead is used as a thermal stabiliser. These cards are a component of disposable cartridges used in diagnostic medical analyzers that may enable precise measurement of certain analytes on a single entire blood sample, such as sodium, chloride, glucose, pH value, etc. Near the point of care, the medical analyzers are utilised to get blood results quickly (e.g., in emergency departments). Such uses were covered by an earlier exemption in Annex IV of the RoHS Directive. 

The Commission has started a feedback drive about the proposed legislative act that would grant the proposed exemption. The review period closes on February 13, 2023. 

On 23 January 2023 the European Chemicals Agency (ECHA) announced that they will start checking both new registrations and updates to existing registrations of chemicals under REACH against revised re...

On 23 January 2023 the European Chemicals Agency (ECHA) announced that they will start checking both new registrations and updates to existing registrations of chemicals under REACH against revised requirements recently amended by the European Commission. The amended checks will take effect on 1 May 2023. Since the checks will apply to both new and existing registrations, registrants should prepare for the changes because existing registrations may no longer pass the completeness check.

The changes to the completeness checks concern the following areas:

• Substance identity: ensuring correct and consistent identification of a substance’s boundary composition and its constituents and additives based on clarifications made to Annex VI.
• Standard information requirements based on Annexes VII-XI: supporting registrants in reporting information for endpoints concerning mutagenicity, degradation and aquatic toxicity based on Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to provide arguments for the approach in a more structured format.

Registrants are encouraged to use the IUCLID validation assistant to check their registrations before submitting them to ECHA. The new version of IUCLID which will be released at the end of April 2023 will include the amended completeness check rules.

The Model Regulations address consignment processes, the usage, building, testing, and approval of packing and portable tanks, as well as the categorization of dangerous commodities and their listing ...

The Model Regulations address consignment processes, the usage, building, testing, and approval of packing and portable tanks, as well as the categorization of dangerous commodities and their listing (marking, labelling, placarding and documentation). They seek to provide a high degree of safety by preventing incidents involving people, property, and the environment while in transit, while also offering a standardised regulatory framework that may be used globally for national or international transport using any method. 

Recycled plastics are made from plastic that has been cleaned and processed into new packaging from previously used industrial packaging. The particular characteristics of the recycled material used to make new packaging must be guaranteed and routinely documented as part of a quality assurance procedure approved by the appropriate authorities. 

The industry organisations had previously proposed changes to the Model Regulations during a conference in July in order to encourage the use of recycled plastic, including easing limitations on doing so. However, the subcommittee stated that it would prefer to modernise current provisions, therefore the meeting did not approve these ideas.  

At that conference it was advised to co-ordinate efforts with an ISO working group that is examining the requirement for recycled plastics in packaging for dangerous products (ISO 16103:2005). Additionally, a remark in the current definition states that the ISO standard "must be followed." As the present version of the standard is based on experience from 20 years ago and only applies to drums and jerrycans, this has been modified to "may be followed". 

The UN Sub-Committee of Experts on the Transport of Dangerous Goods (SCETDG) met in December and decided to provide the update. It was the result of two proposals, one from Belgium and the other a collaboration between the International Confederation of Plastics Packaging Manufacturers (ICPP) and the Intermediate Bulk Container Associations (ICIBCA). 

According to the current definition, each batch of recycled plastic material has to pass a quality control procedure. The word "batch" is "undefined and it has taken on numerous connotations," according to the ICPP/ICIBCA proposal. It was said that this has an impact on the recycling industry's economic sustainability by raising expenses for lower batch sizes. Therefore, the definition will be changed to specifically state that a batch is "of homogenous composition". 

The update includes a clarification that intermediate bulk containers (IBCs) can be constructed from recycled plastic and will accept plastic from other sources if it complies with specified specifications. 

IBC tanks play a part in providing businesses' products with tough and long-lasting packaging. Its resilience demonstrates its reusability. The function of IBC tanks in circular sustainability implies that intermediate bulk containers can endure use and other circumstances for extended periods of time, so that you do not need to acquire additional lower-quality storage cans or plastics. IBC tanks are manufactured from dependable and sturdy materials. The IBC tanks have the great quality of being reusable. This immense significance is crucial to the circular economy's viability. And among these roles are: 

• Pollution Elimination 

• Compactness. 

• Energy Conservation 

The revision will be included in the Model Regulations' 23rd amended version, which will be released this year and will take effect in January 2025.