Europe Regulatory News

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. 

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 nationa...

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 . 

The detailed proposal will be published by ECHA on February 7th, 2023. This proposal comes after the five authorities identified risks in the manufacture, placement on the market, and use of PFASs that need to be addressed throughout the EU and European Economic Area. ECHA will run the necessary administrative checks before the proposal and supporting documents are made available. 

The next steps include a scientific evaluation by ECHA's scientific committees for Risk Assessment and Socio-Economic Analysis in March 2023, followed by a six-month consultation starting on March 22nd, 2023. The final opinions will be sent to the European Commission and EU Member States for a decision on a potential restriction.  

On 17 January 2023, the European Chemicals Agency (ECHA) announced that 9 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) because of their hazardous propertie...

On 17 January 2023, the European Chemicals Agency (ECHA) announced that 9 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) because of their hazardous properties. This means that the Candidate List now contains 233 entries.

SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. Some of the entries in the Candidate list are groups of chemicals, so the overall 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 authorisation for continued use.

Under REACH there are legal obligations when it comes to substances in the Candidate List. Suppliers must give their customers and consumers information 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 substances on the Candidate List, either on their own or in mixtures, have to provide a Safety Data Sheet to their customers.

Importers and producers of articles that contain a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

The uses of the nine new entries to the Candidate List are for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers, and in the manufacture of pulp and paper. The substances are for example very persistent and very bioaccumulative (vPvB), carcinogenic, toxic for reproduction,  or have endocrine disrupting properties. The new entries included on 17 January 2023 are listed below.

On 13 December 2022 the European Chemicals Agency (ECHA) released a draft of their annual update for the Community Rolling Action plan (CoRAP). Registrants are encouraged to check the draft list of su...

On 13 December 2022 the European Chemicals Agency (ECHA) released a draft of their annual update for the Community Rolling Action plan (CoRAP). Registrants are encouraged to check the draft list of substances planned for evaluation in 2023 and update their dossiers to include all relevant information before March 2023.

The draft CoRAP covers the next three years i.e. 2023-2025. The draft plan was submitted to the Member State Competent Authorities and the ECHA Member State Committee on 30 November 2022. The Committee is expected to give its opinion in February 2023 and ECHA aims to adopt and publish the CoRAP update on 21 March 2023.

The Community Rolling Action Plan contains substances that are suspected to pose a risk to human health and the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that makes it possible to clarify such potential risks.

The draft CoRAP contains 24 substances of which 6 substances are new compared to the current CoRAP 2022-2024. Evaluation of 5 substances is planned for 2023 and the remaining 19 will be divided for evaluation in 2024 and 2025.

The following information is included in the draft CoRAP:

• Non-confidential substance names
• The EC/List numbers and CAS RN
• The initial grounds for concern
• Contact details for the Member State that intends to conduct the substance evaluation

The complete list of substances included in the CoRAP 2023-2025 can be found here.

The Safe and Sustainable by Design (SSbD) is a design, development, production, and use strategy for chemicals and materials that emphasises delivering the desired function (or service) while avoiding...

The Safe and Sustainable by Design (SSbD) is a design, development, production, and use strategy for chemicals and materials that emphasises delivering the desired function (or service) while avoiding or minimising detrimental effects on human health and the environment.  

The SSbD idea incorporates elements for the domain of chemical and material safety, circularity, and functionality, with sustainability consideration throughout their existence, minimising their environmental impact. 

The concept "Safe and Sustainable-by-Design" covers four areas: 

1. Going climate neutral 

2. Driving the circular economy 

3. Enhancing the quality of life 

4. Scaling up digital and tech 

In accordance with the SSbD concept, chemicals are produced/used in a way that maximises their benefits to society while avoiding harm to the planet and people. The production and use of safe and sustainable chemicals in Europe has become a benchmark worldwide. Chemical markets as well as chemical innovation are expected to be shaped in the future by the concept of SSbD. The concept should advance the creation of chemicals that are safe for people and the environment, provide a smaller environmental impact, and provide the expected performance and value to stakeholders along the entire value chain. It should be based on the most recent cutting-edge scientific research. 

On the 8th of December 2022, the European Commission published a “Recommendation” and an “Annex” that together constitute the long-awaited SSbD framework. The SSbD framework contains methods for assessing safety and sustainability features of chemicals.   The European Commission encourages all market stakeholders to use the “Recommendation” in their research and innovation activities. The “Recommendation” is launched at a testing phase with voluntary reporting. 

 The development is guided by the principles outlined in the Annex, which are to be used by industry and other stakeholders. For example, to prevent unfortunate substitutes, a hierarchy that prioritises safety is established. In addition, 'cut-off' criteria for the design of chemicals and materials must be established in order to encourage sustainable research and development. This would be based on the information cited in the chemical regulations of the EU as well as information that is not covered by those requirements, making the best possible use of the information on negative effects. Likewise, to assess the expected likelihood of having a negative impact on human health or the environment, every new chemical or material should be thoroughly compared to existing compounds that are structurally or functionally similar. Additionally, the supply chain should be informed of the SSbD actions taken, and all pertinent and non-confidential data should be made available in a high-quality findable, accessible, interoperable and reusable (FAIR) format for greater transparency and accountability. 

The outcomes from the current framework will direct efforts to build grading systems and standards as well as criteria for "Safe and Sustainable by Design." The Commission will begin the process of developing the criteria during the review stage of the input evaluation. The official criteria will most likely be published in 2025.