Europe Regulatory News

The European Chemical Agency (ECHA) recently organized a workshop on New Approach Methodologies (NAMs) with over 500 participants to discuss ways to replace animal testing in the hazard assessment of ...

The European Chemical Agency (ECHA) recently organized a workshop on New Approach Methodologies (NAMs) with over 500 participants to discuss ways to replace animal testing in the hazard assessment of industrial chemicals while at the same time ensuring a high level of protection of human health and the environment.

The workshop aimed to achieve a common understanding of what short and long-time goals can be realized with NAMs. Some issues discussed at the workshop were:

• Potential areas where NAMs could be used to reduce regulatory dependence on data generated with animal tests.

• How to accelerate the regulatory acceptance of NAMs.

• The potential of NAMs to accelerate the pace of assessment while taking ethical values into consideration.

The concluding remarks from the Director for Prioritisation and Integration, Ofelia Bercaru, indicated that ECHA opens the way for animal testing-free chemicals regulation in the future: “ECHA is committed to supporting the development of new methodologies to replace testing on animals. We also want to contribute to future EU chemicals regulation which would not rely on animal testing. This workshop gave us new views and a better understanding on how we can move forward, while implementing horizonal regulations such as REACH and CLP." 

Prior to the workshop ECHA published its fifth report on the use of alternatives to testing on animals for the REACH Regulation. The report finds that progress is being made in the increased use of alternatives to gather data on the properties of substances, in place of animal testing. An example is that there has been a significant increase in the use of in vitro test methods. These are methods that involve studies with cell, tissues, or organs which are used to obtain data for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation. Approximately 50% of the studies conducted for skin and eye irritation in the period 1990-2022 were performed in vitro. For new studies conducted in 2019-2022, this percentage rises to approximately 90%.

The report reveals opportunities and challenges associated with moving away from animal testing in the regulatory assessment of chemicals. Additionally, it presents the initiatives made by ECHA to promote non-animal testing and to increase the acceptance and uptake of NAMs.

On 8 June 2023 the European Commission added 24 new entries for substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) to the REACH Restricted Substance List (Annex XVII). The lis...

On 8 June 2023 the European Commission added 24 new entries for substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) to the REACH Restricted Substance List (Annex XVII). The list of substances was published in an Annex to the Commission Regulation 2023/1132 in the Official Journal of the European Union on 9 June. The Commission Regulation can be found here. The restrictions will come into force on 1 December 2023.

The 24 new substances are classified as Category 1A and 1B CMR substances. Category 1A contains chemical substance for which there is scientific evidence based on humans that the substance is CMR. For Category 1B the scientific evidence is based on animals. Under the REACH regulation substances that are categorised as CMR 1A and 1B cannot be placed on the market or used.

The substances added to Annex XVII include the following:

Furthermore, five existing substance entries in Annex XVII have been amended.

On 14 June 2023, the European Chemicals Agency (ECHA) added two chemicals to the Candidate list of Substances of Very High Concern (SVHC). SVHCs are substances that can have serious and often irrev...

On 14 June 2023, the European Chemicals Agency (ECHA) added two chemicals to the Candidate list of Substances of Very High Concern (SVHC).

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. With the new additions the Candidate list now has 235 entries, some 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.

The first new substance is diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO) which is identified as toxic to reproduction in accordance with Article 57(c) of the REACH Regulation. TPO is primarily used in inks and toners but also in a wide range of products such as photo-chemicals, adhesives, sealants, and polymers. Between 10,000 and 100,000 tonnes are manufactured or imported in the European Economic Area (EEA) every year.

The second new substance is bis(4-chlorophenyl) sulphone (BCPS) which is a very Persistent and very Bio-accumulative (vPVB) substance according to Article 57(e) of the REACH Regulation. BCPS is used industrially to produce polymers, rubbers, and other chemicals. It is manufactured and imported in the EEA in the range of 10,000 to 100,000 tonnes per year.

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.

Furthermore, under the Waste Framework Directive, companies have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 % (weight by weight).

On 15 May 2023, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation. The SCCS Notes of Guidance (NoG) ar...

On 15 May 2023, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation. The SCCS Notes of Guidance (NoG) are revised and updates by the European Commission’s Scientific Committee on Consumer Safety (SCCS) approximately every 3 years, to incorporate the progress in the field of testing and safety evaluation of cosmetic ingredients. The NoG aim to provide guidance to public authorities and the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation (Regulation (EC) No. 1223/2009). The notes contain information on the different aspects of testing and safety evaluation of cosmetic substances with the emphasis on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products.

The updates in the 12th revision of the Notes of Guidance have emphasis on the following aspects:

• Importance of systematic literature review

• Updating of animal-free alternative methods: NAM (New Approach Methodology), changes introduced for acute inhalation, skin irritation testing, eye irritation testing with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin Comet; in vitro micronucleus)

• Importance of AOP (Adverse Outcome Pathway), DAs (Defined Approaches), IATA (Integrated Approaches to Testing and Assessment), NGRA (Next Generation Risk Assessment) with definition of BER (Bioactivity/Exposure Ratio), TTC (Threshold of Toxicological Concern), iTTC (internal TTC)

• Updating of in silico prediction possibilities

• Exposure data reviewed (models, parameters specific for inhalation, aggregate exposure)

• Exposure of children to different cosmetic product categories according to age

• Sun protection by sunscreen products: rationale behind exposure data

• Human biomonitoring (HBM) and differences with SCCS approach for risk assessment

• Reporting requirements for cancerogenic, mutagenic and reprotoxic substances (CMRs)

• Introduction of non-monotonic dose response, reporting requirements for endocrine active substances

• Templates for PBTK (Physiologically Based ToxicoKinetic) model description and parameter verification and analysis

The full text of the NoG can be found here: https://health.ec.europa.eu/system/files/2023-05/sccs_o_273.pdf

The "Chemicals in Plastics: A Technical Report" released by the UN on 3 May 2023, attempts to educate the world's population on the frequently disregarded chemical-related problems associated with...

The "Chemicals in Plastics: A Technical Report" released by the UN on 3 May 2023, attempts to educate the world's population on the frequently disregarded chemical-related problems associated with plastic pollution, including their detrimental effects on human health and the environment, resource efficiency, and circularity.  It further emphasises the urgent need for action and provides potential areas for action based on convincing scientific evidence.  Additionally, it aims to aid in the development of the plastic pollution instrument based on resolution 5/14 of the United Nations Environment Assembly. Several reliable and openly accessible research studies and projects pertaining to chemicals in plastics and the intersection of science and policy are described in the report. 

According to the report, more than 13,000 chemicals have been linked to plastics and plastic manufacture in the most recent studies, out of these more than 3,200 plastic monomers, additives, processing aids, and non-intentionally added substances (NIAS) have been identified as chemicals of potential concern based on their hazardous qualities and 7,000 compounds have been evaluated for their hazardous properties.    

The following table lists priority industries, along with a list of the chemicals that should be of particular concern: 

Chemicals in plastics: Exposure of the ecosystem and people 

Plastics in the environment deteriorate and fragment into smaller pieces to generate microplastics and nanoplastics as a result of exposure to sunshine, wind, and waves. Other processes that can break down plastics include biodegradation, photodegradation, thermal degradation, and hydrolysis. In contrast to underground, underwater (such as in the deep sea), or in non-surface polar conditions where UV radiation and mechanical erosion are negligible, plastics are more prone to deteriorate on surface soil, surface water, or in the air. Plastics are very persistent in the environment, though, as the bulk of them are produced from non-biodegradable polymers and contain additives like UV stabilisers, antioxidants, and heat stabilisers that are meant to keep them durable. 

Chemicals linked to plastic are particularly dangerous to women and children. Exposures can negatively affect a woman during numerous important stages of her life and even affect future generations. For instance, exposures during foetal development and in children can result in problems related to neurodevelopment and neurobehavioral processes. Men are not exempt either, as recent studies show that significant negative impacts on male fertility are caused by existing combined exposures to dangerous chemicals, many of which are linked to plastics. 

Replacing chemicals and plastic with more environmentally friendly substitutes 

Since using drop-in chemicals (i.e., replacement chemicals that can be utilised without affecting existing production processes) is easiest and frequently seen as most technically viable, dangerous chemicals in plastics are currently generally substituted chemical-by-chemical. 

However, it is frequently necessary to consider several other options in addition to particular drop-in chemicals from a much wider perspective. Drop-in chemicals frequently have physicochemical features that are strikingly similar to those of the chemicals they replace; as a result, they may have effects on human and environmental health that are comparable to or even worse. 

PLASTIC WASTE MANAGEMENT IN A CIRCULAR ECONOMY 

As per the UN-report the following key points can be referred for the waste management. 

1. Global plastic flow and waste management 

2. Challenges of recycling, energy recovery and managing plastics containing hazardous chemicals 

3. Options for recycling and managing plastics containing hazardous chemicals. 

4. Developing capacity for waste management, recycling, recovery, and destruction 

On 17 April 2023 the European Commission notified proposed revision of the Classification, Labelling and Packaging (CLP) Regulation to the WTO. The proposal was originally published on 19 December 202...

On 17 April 2023 the European Commission notified proposed revision of the Classification, Labelling and Packaging (CLP) Regulation to the WTO. The proposal was originally published on 19 December 2023.  The revision of the CLP and the planned revision of REACH are important parts of the Chemicals Strategy for Sustainability (CSS) framework which again is a key building block of the European Green Deal. The revision package aims to:

• Ensure that all hazardous chemicals including those with endocrine disruptive (ED), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), and very persistent and very mobile (vPvM) properties are classified adequately and uniformly throughout the EU. The new hazard classes are already implemented through the Delegated Act of 20 April 2023. Read more here.

• Improve the efficiency of hazard communication by making labels more accessible and understandable for users of chemicals. Provide companies with more flexibility and thereby reducing the administrative burden without lowering safety levels.

• Ensure that the rules on chemical hazard classification and communication are applied by all relevant actors in the supply chain.

The revised regulation will be clearer on labelling issues such as readability and digital labelling. It will also increase compliance with CLP for online sales of chemicals. This will help businesses, including SMEs and the free movement of substances and mixtures within the EU market. The revision will introduce the following:

• Better and faster processes for all actors to inform on hazards of chemicals placed on the EU market.

• Improved communication of chemical hazards, including online, through simpler and clarified labelling and advertising requirements.

• The right for the European Commission (in addition to Member States and industry) to develop classification proposals on potentially hazardous substances, speeding up the pace at which hazardous substances can be identified.

• The first ever specific rules for refillable chemical products so consumers buy and use these products (e.g. home care chemicals) in a safe way.

The proposal in currently undergoing the Ordinary Legislative Procedure. The EU Parliament and the EU Council are expected to formally adopt the new legislation in the first quarter of 2024.

On 5 May 2023 the European Food Safety Authority (EFSA) requested additional evidence regarding the potential migration of plasticisers from food contact materials (FCMs). Stakeholders and interested ...

On 5 May 2023 the European Food Safety Authority (EFSA) requested additional evidence regarding the potential migration of plasticisers from food contact materials (FCMs). Stakeholders and interested parties can submit their information until 30 June 2023.

Upon the European Commission's request, EFSA is conducting a re-evaluation of phthalates, substances with similar structures, and alternative materials utilized in FCMs. To facilitate this process, EFSA has extended an invitation for data submissions from various entities, including national food authorities, research institutions, academia, and food business operators.

This is the second call for evidence on migration data in relation to dietary exposure assessment, following a consultation conducted last year. Phthalates, terephthalates, citrates, and benzoates are some of the plasticisers that will be evaluated.

Previously, in January 2023, the European Commission proposed an update to the regulation governing plastics used in FCMs. This proposed update would introduce changes to existing authorizations and specific migration limits (SMLs) for certain uses of phthalates such as dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diethylhexyl phthalate (DEHP), and diisononyl phthalate (DINP).