Europe Regulatory News

On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which production includes the use of formaldehyde...

On May 2, 2022, the European Union released a draft to amend Annex XVII to Regulation (EC) No 1907/2006. The new amendment mainly concerns articles in which production includes the use of formaldehyde or formaldehyde-releasing substances that releases the substance into indoor air in concentrations beyond the limit. It also refers to road vehicles that have formaldehyde or formaldehyde-releasing substances added in their productions in which concentration in the vehicles’ interiors is higher than the allowed limit.

The new amendment specifies the limit for wood-based articles and furniture at 0.062mg/m³ and other articles at 0.08mg/m^3. For road vehicles, the restriction is set at 0,062mg/m³. Therefore, concerned products beyond the stipulated concentration limit cannot be placed on the market.

The new restriction is expected to come into force 36 months after its entry (for concerned articles) and 48 months after entry into force for road vehicles.

According to the American Cancer Society, Formaldehyde is an organic compound, a colourless gas with a strong smell used in producing building materials, household products and vehicles. The common way to be exposed to the substance is through inhalation which studies have shown to cause cancer in humans. The main aim of the new restriction is to reduce exposure to formaldehyde and protect the general public from such exposure.

The proposed date of adoption is the last quarter of 2022 and the proposed date of entry into force will be 20 days from its publication in the EU official journal. All comments are expected 60 days (July 1, 2022) from its notification (May 2, 2022).

A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ production. The expectation is to develop lead-...

A leading European research institute, Oeko-Institut opened a consultation to exempt lead restriction under the EU RoHS Directive for medical devices’ production. The expectation is to develop lead-free alternatives, which have been delayed due to the COVID-19 pandemic.

Representing the European Commission, the institute is assessing the application for use of lead in polyvinyl chloride (PVC) as a thermal stabiliser. Also, it is a base material used in amperometric, potentiometric and conductometric electrochemical sensors, all present in medical devices.

Previously, the EU gave an exemption on the restriction of hazardous substances (RoHS) in electrical and electronic equipment. This exemption expired in March and this new exemption is expected to remain for two years.

This decision was made in consideration of the delay that hospitals experience in using medical devices for patients, mainly to analyse creatinine and blood urea nitrogen in whole blood.

To comment on this consultation, you have till May 19 after which a decision might be made. You can view the exemption request here.

On May 3, 2022, the European Parliament voted on a European Commission proposal to tighten the limits for the presence of Persistent Organic Pollutants (POPs) in waste. The proposal was earlier adopte...

On May 3, 2022, the European Parliament voted on a European Commission proposal to tighten the limits for the presence of Persistent Organic Pollutants (POPs) in waste. The proposal was earlier adopted by the European Commission.

The presence of POPs in waste is a barrier to the development of a circular economy, one of the major objectives of the European Green Deal.

The Commission proposal was presented on 28 October 2021. It would amend Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants, introducing limits for the presence of the following POPs in waste:

• perfluorooctanoic acid (PFOA) and its salts and related compounds – found in waterproof textiles and fire-fighting foams;
• dicofol – a pesticide, previously used in agriculture;
• pentachlorophenol, its salts, and esters – found in treated wood and textiles

Additionally, it would tighten maximum limits for some POPs already included in the Regulation.

While the Parliament agrees with the overall approach of the Commission’s proposal, it is suggesting more strict maximum limits in order to achieve the vision set out under the European Green Deal’s Zero Pollution Action Plan and Chemicals Strategy for Sustainability.  

Parliament is also proposing that the Commission assess whether it would be convenient to amend EU waste legislation to recognize that waste exceeding the thresholds of the POPs Regulation is hazardous waste.

Negotiations between Parliament and the Council of the EU, representing the Member States, will now begin. Both institutions must agree on a final text, which will then become law.

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).