Europe Regulatory News

Opposition against the proposed draft changes on ECHA’s intermediates guidance from the German industry body has been strongly expressed. Their claim was that the modified original proposal defies a...

Opposition against the proposed draft changes on ECHA’s intermediates guidance from the German industry body has been strongly expressed. Their claim was that the modified original proposal defies a 2017 court ruling. This modification made earlier has drawn censuring from the industry as well as concerns from Glass Alliance Europe, calling for ECHA and the Commission to reconsider and to correct ECHA’s interpretation of the ruling.

In the hope of settling this long-lasting trade-off with industries, ECHA received flying criticism after ECHA and the Commission further curbed the number of permitted intermediate uses in an initial position paper via publication of this revision this March. Yet, the “main aim” conditions introduced still failed to meet the satisfaction of organizations such as BDI, where they disapproved of counting substance manufacturing as part of the transformation process, in which intermediate would partake.

This main aim was not the only part the Federation of German Industries (BDI) opposed to; other interpretations from ECHA regarding the concept of synthesis where transformation takes place, and to confine substances to controlled environments were also retorted by BDI. Seeing from the acrylamide judgement, BDI did not accept these additional conditions demanded, which in their opinion were beyond the legal requirements of REACH. Processes that have met all three cumulative conditions placed by the European Court of Justice (ECJ) could nonetheless still be excluded as their intended results are not solely substance manufacturing via synthesis. Towards this unlawful differentiation in chemical use, BDI thus called for ECHA to yet considerably amend the guidance.

On the other hand, supports for the draft guidance were seen from the Dutch National Institute for Public Health and the Environment (RIVM), basing on the draft’s positive potential to minimize the substance exposure of intermediate to the environment more strictly. Regarding the divided interpretation, RIVM suggested revisiting the definition under REACH to ensure the conditions as well as intermediate uses were comprehended in the same manner for all parties.

Though no official consultation had been requested, ECHA expressed their willingness to consider constructive comments irrelevant to the discussion on the principles as they only want to improve clarification and comprehension of the draft. ECHA showed reluctance to scrutinize comments on principles all over again, for the resources shall be reserved for legal text review.

The next Caracal meeting happening on May 20, 2022, is scheduled to endorse the document, where the current changes are deemed temporary until the definition of intermediates stated in REACH Article 3(15) is rescripted in the next revision of the law. If the endorsement fails, the updates will not be published; anyhow, since the guidance has not yet been considered fully aligned with the ECJ judgement, the updated version will likely be withdrawn.

The European Commission published, on April 25, 2022, a list of substances and substance groups for which restrictions under the REACH Regulation are being proposed, prepared, or considered.   ...

The European Commission published, on April 25, 2022, a list of substances and substance groups for which restrictions under the REACH Regulation are being proposed, prepared, or considered.

One of the lines of action under the European Union Chemicals Strategy for Sustainability is the coordination and prioritization of restriction proposals. After a process involving all the relevant authorities (the Commission, ECHA, and Member State Competent Authorities), the newly published “Restrictions Roadmap under the Chemicals Strategy for Sustainability[DT1] ” provides an overview of the different substances being considered for restriction.

The Roadmap establishes a Rolling List of substances for restriction, which categorizes proposals into three groups:

1. Restrictions for which formal procedures have already started
2. Restrictions on which preparatory work has been done, but haven’t been formally proposed yet
3. Restrictions (or revisions of restrictions) that are being discussed as one among other management options

In addition to the status of restriction proposals, the Rolling List contains information on the uses covered by the restriction and a tentative date for the submission of the restriction dossier.

The Rolling List is not legally binding. Therefore, substances included might not be proposed for restriction eventually, and – conversely – restrictions may be proposed for substances not included. To preserve clarity and predictability, it will be updated regularly to reflect the decision making status on restrictions.

GPC is closely observing developments in relation to the EU’s Chemicals Strategy for Sustainability. Download our latest Regulatory Summary of EU Chemical policies to stay updated. 

You can also download the roadmap here.

In March, the European Commission adopted REACH authorization decisions for the use of four chemicals that are listed in Annex XIV of the law. CTPht is on the REACH authorization list for its carc...

In March, the European Commission adopted REACH authorization decisions for the use of four chemicals that are listed in Annex XIV of the law.

CTPht is on the REACH authorization list for its carcinogenic, persistent, bioaccumulative and toxic (PBT), and very persistent, very bioaccumulative (vPvB) properties. And 4-tert-OPnEO and 4-NPnEO are on the list for their endocrine-disrupting properties when they degrade which affects the environment.  

However, the Commission rejects two authorization requests for the use of CTPht as a binder in producing clay targets. The reason is that the application did not show if and how the socio-economic benefits outweigh the risks to human health and the environment. Check the table below for the substances that have review dates.

On the 29th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009). The objective of this revision is to ensure hum...

On the 29^th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009).

The objective of this revision is to ensure human health and improve the functioning of the internal market. It will focus on four key points:

• The use of nanomaterials in cosmetics and their definition
• The application of a generic approach on risk management (GRA) to ensure that cosmetics do not contain CMRs (carcinogenic, mutagenic, or toxic for reproduction) substances, or substances that affect the endocrine system (endocrine disruptors) or are persistent and bioaccumulative.
• Reattributing assessments of substances used in cosmetics to be lined-up with the Scientific Committee on Consumer Safety (SCCS)’s approach: “one substance, One assessment”.
• Simplification and the digitalisation of the labelling requirements.

In its preliminary assessment, the European Commission expects positive impacts in various aspects such as economy, social, and environmental. Moreover, the revision of the Cosmetic Product Regulation could have positive effects on administrative burden as it aims to harmonise the different chemical legislations and simplify the processes of compliance checks of the products.

The consultation will close on the 21^st of June and the following stakeholders are welcome to contribute to the consultation: Citizens and consumers, Professional users of cosmetic products, Manufacturers, Importers, Distributors, and other businesses (SME, Industry and SME associations, civil society organisations, member state authorities, market surveillance authorities, customs authorities, any other interested stakeholder).

The EU has announced that the ban on Per- and Polyfluoroalkyl Substances (PFASs) will not include the essential use criteria. This is because the essential use criteria will not be ready at the right ...

The EU has announced that the ban on Per- and Polyfluoroalkyl Substances (PFASs) will not include the essential use criteria. This is because the essential use criteria will not be ready at the right time for the restriction proposal. The essential criteria are expected to be agreed on by the end of the year whereas the PFASs restriction process has already started.  

Due to these different timelines, the strategy to ban all uses of PFASs expect the essential use criteria will still be adapted. However, the restriction proposal will rely on existing tools to analyse the substances within this category to determine if there are safer alternatives or not, thereby determining if such substance use is essential or not. 

Due to the dossier’s complexity, the submission of the joint restriction proposal by Netherlands, Germany, Sweden, Denmark, and Norway has been postponed to January 2023, giving them a six month extension. Also, the ban’s implementation may be pushed back from 2025. 

Regarding the restrictions that are already in place for specific PFASs such as the ones used in firefighting foams, and the ones banned in persistent organic pollutants (POPs) Regulation, the Commission will decide if these existing restrictions are to be separate or merged with the universal restriction.  

The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties.  These substances include: ...

The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties. 

These substances include:

1. tetraethyl lead,
2. 4,4'-bis(dimethylamino)-4"-(methylamino)trityl alcohol with ≥ 0.1% of Michler's ketone or base,
3. reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl)
4. 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia4-stannatetradecanoate (DOTE)
5. reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4- octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)

This amendment to Annex XIV is expected to take effect from April 28, 2022. For transitional arrangements, industry has till November 1, 2023, to apply for their use authorisation. Furthermore, these five substances are prohibited from market placement and use from May 1, 2025, except for companies that are granted authorisation.

On March 22, 2022, the European Commission held its second stakeholders’ workshop on “Safe and Sustainable by design (SSbD) criteria for chemicals and materials”. The development of criteria to ...

On March 22, 2022, the European Commission held its second stakeholders’ workshop on “Safe and Sustainable by design (SSbD) criteria for chemicals and materials”. The development of criteria to assess the safety and sustainability of chemical substances is one of the main actions under the EU’s Chemicals Strategy for Sustainability.  While the relation of these criteria to specific regulatory initiatives is still unclear, they will be of immediate relevance for non-legislative initiatives and set an official definition that may serve as a basis for compliance obligations at a later stage.

At the workshop, European Commission representatives and stakeholders from civil society organisations and the chemicals industry discussed the overall framework for the assessment of the safety and sustainability of chemicals. The Commission expects to hold a follow-up webinar in April, where it will respond to the feedback provided by stakeholders.

The current proposal by the European Commission’s Joint Research Centre consists of a 4-step process. Three of the steps would relate to the safety of a chemical. Specifically, they would address its properties, its processing, and its uses. The fourth and final step would assess the environmental performance of a chemical from a life-cycle perspective.

The workshop is the second one of a series of three. A first workshop, held on 19 March 2022, presented the framework and timeline for the development of the SSbD criteria. A third and final workshop will be held in the third quarter of 2022, where specific case studies will be discussed before publication by the Commission of the criteria. The case studies currently under consideration are non-phthalate plasticisers, surfactants, and halogen-free flame retardants.

GPC is closely observing developments in relation to the EU’s Chemicals Strategy for Sustainability. Download our latest Regulatory Summary of EU Chemical policies to stay updated. 

Download here.