Europe Regulatory News

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).

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions lis...

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions list of substances for global elimination (Annex A). The delegates to the COP found that the chemicals, the plastic additive UV-328, the flame retardant Dechlorane Plus (also often used in plastics), and the pesticide methoxychlor all meet the Convention criteria as persistent organic pollutants (POPs) required for a global ban.

The uses and hazards of the 3 substances are:

However, time-limited exemptions were agreed on for the use of UV-328 and Dechlorane Plus. The expemtions are summarised in the tables below.

Several countries called for labelling of products that contain the 2 plastic additives while others opposed. The Convention’s Scientific Review Committee plans to evaluate options for identifying POPs in products and waste.

On 28 April 2023 the European Commission put forward a proposal for a revised Regulation on detergents and surfactants that would amend Regulation (EU) 2019/1020 and repeal Regulation (EC) No 648/2004...

On 28 April 2023 the European Commission put forward a proposal for a revised Regulation on detergents and surfactants that would amend Regulation (EU) 2019/1020 and repeal Regulation (EC) No 648/2004. The new proposal introduces digital labelling and product passports for detergents and surfactants, new requirements for cleaners containing micro-organisms as well as rules for refilled detergents. This proposal updates the existing rules in line with the objectives of the European Green Deal, the Chemicals Strategy for Sustainability and the recently adopted Commission Communication on the long-term competitiveness of the EU.

Detergents are chemicals with intrinsic properties that have the potential to pose risks to human health and the environment. In order to be placed and move freely on the EU market detergents need to comply with Regulation (EC) No 648/2004 (the ‘Detergents Regulation’) from 2004. The regulation contains labelling and biodegradability requirements and phosphorous limits. However. the Detergents Regulation does not take into account innovative products such as microbial cleaning products and sustainable new practises such as refill sales. Furthermore, there are overlaps between the Detergent Regulation and the Classification, Labelling and Packaging (CLP) Regulations leading to e.g. duplication of information of the emergency health response for detergents classified as hazardous under the CLP Regulation. The revised Regulations will address these issues.

The revised Regulation will ensure that the EU rules specific for detergents remain complementary to the general provisions applicable to chemicals i.e. the CLP Regulation and the REACH regulation. The revised Regulation puts forward the following changes:

Introduction of safety requirements for micro-organisms in detergents: New innovative cleaning products that use the action of micro-organisms have recently been developed. The revised Regulation will introduce safety requirements for micro-organisms in detergents. Furthermore, manufacturers must label the presence of micro-organisms in the detergents. This will allow these products to move freely in the Single Market and contribute to protecting human health and the environment since they may be alternatives to harmful chemicals.

Introduction of product passports: A product passport that contains compliance information will be introduced which will reduce the amount of non-compliant detergents and surfactants on the market in the EU. A detergent that is presented at customs can only be released for free circulation ad placed on the market if it has a corresponding product passport. National inspectors will continue to be responsible for carrying out checks on products, although a new IT system will screen all digital product passports at the external borders.

Introduction of voluntary digital labelling: For pre-packaged products some of the mandatory labelling information may be move to a digital label. For refillable products all labelling information may be provided digitally – except for dosage instructions for consumer laundry detergents.

Introduction of rules for refilled detergents: Under the revised Regulation refilled detergents are subject to the same rules as pre-packaged detergents. Furthermore, voluntary digital labelling is introduced for refilled detergents to further facilitate the use of these as this is sustainable and reduces packaging waste.

Simplification of market rules by abolishing unnecessary or redundant requirements: The following rules in the Detergent Regulation will be abolished:

• the obligation to provide an ingredient data sheet for hazardous detergents

• the obligatory involvement of approved laboratories performing tests

• the possibility to request a derogation for surfactants that do not meet the criteria of ultimate biodegradability

• the obligation for detergent and surfactant manufacturers to be established in the EU

Furthermore labelling requirements will be simplified and streamlined to reduce the administrative burden for the industry and making them easier to understand for end-users.

The complete text of the revised Regulation can be found here: https://single-market-economy.ec.europa.eu/publications/com2023217-proposal-regulation-detergents-and-surfactants_en

The European Commission has finally adopted restrictions prohibiting the use and sale of lead in polyvinyl chloride (PVC) articles, including imports in order to safeguard individuals and the environm...

The European Commission has finally adopted restrictions prohibiting the use and sale of lead in polyvinyl chloride (PVC) articles, including imports in order to safeguard individuals and the environment against the harmful impacts of lead. The primary beneficiaries of this measure are people's health, especially children. These efforts align with the objectives of the Chemical Strategy for Sustainability and the European Green Deal.

Lead compounds are commonly found in PVC products used in the construction industry, such as window profiles, pipes, tubes, wires, and cables. Implemented within the framework of EU REACH, this restriction is expected to prevent the release of approximately 8.4 tonnes of lead emissions annually.

Since the regulation’s entry into force on 28 May, the industry has 18 months to transition and must now add a warning label to the packaging of relevant products.

To encourage recycling and reduce carbon emissions by 1.5 million tonnes annually, items made from recycled rigid PVC can still be sold and used for ten years after the 28 May entry into force. However, only if the rigid PVC contains less than 1.5% lead in the recovered rigid PVC, and less than 0.1% lead for a layer of newly produced PVC. Furthermore, these recycled rigid PVC items must be entirely coated with a lead-free layer to ensure safety and prevent accidental exposure to lead for both people and the environment.