Europe Regulatory News

On 7 December 2023, the European Commission proposed a package of three legislative proposals to reform chemical assessments to make the process faster, simpler and more transparent. The ‘one subst...

On 7 December 2023, the European Commission proposed a package of three legislative proposals to reform chemical assessments to make the process faster, simpler and more transparent. The ‘one substance one assessment’ package aims to streamline the assessments of chemicals across EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.

The package involves reallocating tasks between four EU agencies to ensure coherent and transparent assessments of chemicals used in a wide range of products, including medical devices, toys, food, pesticides, and biocides.

Key points of the legislative proposals

The three legislative proposals are part of the Commission’s Chemicals Strategy for Sustainability (CSS) and aim to achieve better prevention through improved chemicals data management. The key points are:

Establishment of a Common Data Platform: The platform will provide access to all data compiled under EU legislation and held by the EU agencies and the Commission. The Common Data Platform will integrate existing platforms such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU Chemicals Legislation Finder (EUCLEF). It will include data on hazards, physico-chemical properties, environmental occurrence, emissions, uses, environmental sustainability of chemicals, and ongoing regulatory processes.

Redistributing tasks and improving of cooperation between EU agencies: To avoid the inefficient use of resources and unnecessary costs of having multiple committees carrying out similar assessments, the aim is to strengthen cooperation and consolidate scientific and technical work on chemicals in the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA). The agencies will be better equipped to coordinate priorities, timelines, processes, and methodologies used for the assessment of chemicals. Moreover, knowledge gained from assessments under one piece of legislation (e.g. biocides) can be re-used for another one (e.g. toys).

Human biomonitoring data collection: A systematic collection of human biomonitoring data (e.g. from blood or breast milk) generated in the EU will be used to estimate the level of exposure of EU citizens to chemicals.

Establishment of a monitoring and outlook framework: Such a framework will allow early detection of chemical risks, such as PFAS, to prevent contamination from becoming widespread. It will facilitate a rapid regulatory response and track the impact of regulatory measures implemented on chemicals. The framework will include an early warning and action system, and a set of indicators,

Enable the European Chemicals Agency (ECHA) to generate data as needed.

Ensure transparency of scientific studies on chemicals, including those commissioned by companies.

The full text of the three proposed regulations can be accessed here, here, and here.

Next steps

The three proposals will now be discussed by the European Parliament and the Council under the ordinary legislative procedure.

On November 28, 2023, the European Commission launched a consultation on a draft Act concerning the persistent organic pollutant (POP) hexabromocyclododecane (HBCDD). The Commission aims to eliminate ...

On November 28, 2023, the European Commission launched a consultation on a draft Act concerning the persistent organic pollutant (POP) hexabromocyclododecane (HBCDD). The Commission aims to eliminate or severely restrict the use and production of POPs, as those terms are defined in the Stockholm Convention, in order to protect both the environment and human health. Comments on the draft Act are welcome for four weeks, until December 26. 

Some background 

A class of organic substances known as persistent organic pollutants (POPs) are hazardous to human health and the environment because they persist in the environment, accumulate in food chains, and have poisonous qualities. Because of their persistence, these compounds may be carried across international borders by migratory animals, air, and water far from their source. POPs include industrial compounds like polychlorinated biphenyls and terphenyls (PCBs/PCTs), insecticides like dichlorodiphenyltrichloroethane (DDT), and unintentional byproducts of industrial processes like dioxins and furans. The EU has developed specific regulations to address some of these chemical waste streams. In order to do this, it will update the concentration limit values for some compounds in annexes IV and V of the POPs regulation (Regulation (EU) 2019/1021 on persistent organic pollutants) and add some substances to annex IV of that regulation. 

Draft Act 

Hexabromocyclododecane (HBCDD), which is listed in Annex I of Regulation (EU) 2019/1021, is the subject of this draft Act. The Act lowers the limit value—which was previously set at 100 mg/kg—for the unintentional trace contaminant HBCDD in chemicals, mixtures, and products. Nonetheless, there is an exception and a restriction of less than 100 mg/kg for the use of recycled polystyrene in the manufacturing of expanded polystyrene (EPS) and extruded polystyrene (XPS) insulation for use in buildings or civil engineering projects. The Commission will analyse and evaluate this by January 1, 2026. 

More details about properties and uses of HBCDD as well as available alternatives to HCBCDD can be found here. 

On 22 November 2023, the European Chemicals Agency (ECHA) published an investigation report on PVC and PVC additives. The investigation was carried out by ECHA at the request of the European Commissio...

On 22 November 2023, the European Chemicals Agency (ECHA) published an investigation report on PVC and PVC additives. The investigation was carried out by ECHA at the request of the European Commission to help the Commission determine how to control potential risks from PVC additives and PVC. The investigation found that some substances such as plasticisers, that are added to polyvinyl chloride (PVC) plastic, can potentially pose risks to human health and the environment. It also concluded that regulatory action is needed to limit the use of such additives and to minimise the release of PVC microparticles.

PVC additives

The polymer PVC needs to be combined with specific additives before it can be converted into products. The additives play an important role in determining the flexibility, stability, colour, clarity, and electrical properties of PVC products.

Some additives used in PVC such as stabilisers containing cadmium- and lead and certain phthalates have been found to pose an unacceptable risk to human health and the environment. As a result, these additives are now restricted under REACH. In addition, studies are underway to assess the risks associated with other additives such as medium-chain chlorinated paraffins and flame retardants.

Conclusions

The study focused on 63 PVC additives selected from an initial list of 470 substances. The 63 substances are plasticisers, heat stabilisers and flame retardants (the full lists can be found here). The main findings of the report suggest that regulatory action is needed in the following areas:

• To minimise risks from plasticisers, in particular ortho-phthalates which have already been confirmed to be reprotoxic or endocrine disruptors. Suitable regulatory action is REACH restriction.

• To reduce risks from organo-tin substances (such as DOTE) used as heat stabilisers, which can cause developmental malformations and reproductive problems. Suitable regulatory action is REACH restriction in combination with other measures.

• To ensure that releases of PVC microparticles and prioritised PVC additives are minimised. Technologies to minimise emissions of PVC microparticles at recycling facilities and landfills must be implemented and improved. The microparticles contain the harmful additives so minimising the emissions would consequently reduce emissions of the additives.

• To reduce emissions of flame retardants, which contribute significantly to the emission of the prioritised additives, as proposed in ECHA’s strategy on flame retardants.

The risks posed by PVC resin to workers and the environment are considered to be adequately controlled by the current operating conditions and safety measures implemented by companies. This conclusion follows an analysis of the materials used to produce of PVC resin, the production process itself, waste management practises, and exposure to PVC dust.

The full text of the report can be accessed here.

Next steps

ECHA’s investigation report has now been sent to the European Commission. The Commission will evaluate the report and decide whether there is a need to formally request ECHA to prepare a proposal for a restriction under REACH.

Following the latest meeting of EU’s Scientific Committee on Consumer Safety (SCCS) on 26 October 2023 the Committee published its final opinions on the fragrance benzyl salicylate, the preservative...

Following the latest meeting of EU’s Scientific Committee on Consumer Safety (SCCS) on 26 October 2023 the Committee published its final opinions on the fragrance benzyl salicylate, the preservative butylparaben, the nanomaterial fullerenes in cosmetic ingredients, and water-soluble zinc salts used in oral hygiene products.  

SCCS Final Opinions  

Benzyl salicylate: The SCCS considers benzyl salicylate to be safe when used up to maximum concentrations, based on data and concerns about potential endocrine disrupting properties. However, there is no evidence of endocrine effects, and the SCCS mandates do not address environmental aspects, so this assessment does not assess the safety of benzyl salicylate for the environment. 

Butyl paraben: The SCCS concluded that the use butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% is safe based on the available data and concerns about endocrine activity. However, due to the lack of exposure data for children, potential safety concerns cannot be excluded. 

Water soluble zinc salts: The SCCS has concluded that the use of zinc in toothpaste and diet is safe, except for children under 1 year of age, as the intake exceeds the upper limit level. For children aged 6 months to 1 year, a safe concentration of 0.72% is recommended. Mouthwash with 0.1% zinc is safe for all ages over 6 years. 

Fullerenes: The Safety Commission for Cosmetics (SCCS) cannot conclude on the safety of fullerenes and (hydrated) hydroxylated forms of fullerenes due to uncertainties and data gaps in physicochemical, toxicokinetic, and toxicological aspects. The SCCS cannot exclude the potential for genotoxicity of fullerenes (C60 and C70) and hydrated forms of hydroxylated fullerenes, which are genotoxic. The SCCS has concerns about the presence of impurities, heavy metals, contaminants, organic solvents, stability, ability to induce free oxygen radicals, phototoxicity, sensitizing potential, dermal absorption, systemic availability, and potential distribution to organs. The available evidence is not sufficient to exclude the genotoxic/carcinogenic potential of any of the materials assessed in this Opinion. 

Even discussed at the SCCS meeting 

The SCCS also published the preliminary opinion on hydroxypropyl-p-phenylenediamine-and-its-dihydrochloride-salt and hexyl salicylate. Based on animal studies, the SCCS considers hydroxypropyl p-phenylenediamine and its dihydrochloride salt safe for use in oxidative hair colouring products at 2% on-head concentration but warns of mild to moderate eye irritation and moderate skin sensitizer. More details about the consultation on the preliminary opinion on the use of hydroxypropyl p-phenylenediamine and its dihydrochloride salt can be found here. 

Silver zinc zeolite and methyl paraben will be further discussed in the next working group meeting, together with the SCCS responses to the comments received. 

In an effort to achieve net-zero emissions by the middle of the century, the European Commission is planning to propose a system for certifying the removal of carbon dioxide from the environment.  ...

In an effort to achieve net-zero emissions by the middle of the century, the European Commission is planning to propose a system for certifying the removal of carbon dioxide from the environment. 

How does carbon removals work? 

Activities that remove carbon dioxide from the atmosphere and store it permanently are known as carbon removals.  

There are numerous approaches to accomplish this, such as: 

• Removing carbon directly from the air and storing it in a stable state for permanent storage. 

• Carbon farming, or practises that improve carbon sequestration in soil and forest (e.g., wetland and peatland management, forest restoration). 

• Carbon storage in products (for instance, wood-based structures store carbon that is sequestered by trees). 

In addition to increasing carbon reductions, the EU must accelerate its 2050 climate neutrality goal in order to compensate for residual emissions that are anticipated from industries like manufacturing and agriculture. 

Today, the natural carbon cycle is carried out by nature, mostly by forests, soils, and oceans, which absorb CO2. Reforestation and "carbon farming" techniques, which capture CO2 from the atmosphere and store it in soil or plant material, can promote these natural processes. 

EU carbon removal certification scheme 

In November 2022 the European Commission suggested the creation of an EU-wide carbon removal certification programme to promote and accelerate the implementation of efficient, high-quality carbon removal operations. 

Certification would guarantee precise measurement of carbon removal activities, long-term storage of carbon, and support, or at the very least not hinder, other environmental objectives such as biodiversity, zero pollution, and the circular economy. 

A unified certification programme would build confidence and direct funding from public and private sources towards carbon reduction initiatives. 

Members of the European Parliament (MEPs) stressed the need to create an "EU registry" to maintain openness, disseminate information to the public, reduce the possibility of fraud, and prevent duplicate counting of carbon reductions, The system must also comply with international standards. 

Additionally, MEPs believed it is necessary to differentiate between the definitions, quality standards, and regulations for carbon removals, carbon farming, and carbon storage in products, due to their differences and environmental impacts. 

Next decisions 

Now that the Parliament is ready, talks with EU member states can begin. 

On 15 November 2023, the Swedish Chemicals Agency (KEMI) expanded its PRIO database by adding 5700 new per- and polyfluoroalkyl substances (PFAS). This update brings the total number of PFAS substance...

On 15 November 2023, the Swedish Chemicals Agency (KEMI) expanded its PRIO database by adding 5700 new per- and polyfluoroalkyl substances (PFAS). This update brings the total number of PFAS substances in the database to nearly 11,000. The comprehensive database serves as a valuable resource to help producers and purchasers identify which substances to avoid.

The PRIO database

The PRIO database is a web-based tool that contains more than 16,500 hazardous substances. It lists chemical substances with properties that are hazardous to human health and the environment. Although it is not a complete list of all hazardous or banned substances present in products on the market, PRIO primarily helps users to identify hazardous substances that are not yet banned in the EU. The database can be searched here.

Substances in the PRIO database are categorised into the following two priority levels:

• Phase-out substances: These are the substances with the most hazardous properties, recommended by KEMI for substitution by less hazardous substances or alternative technical solutions. The criteria include:

  • CMR category 1A or 1B

  • Fluorinated greenhouse gases

  • Endocrine disrupting

  • Highly allergenic (Respiratory sensitising category 1A or skin sensitising category 1A)

  • Ozone depleting             

  • Persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB)

  • Particularly hazardous metals (mercury, cadmium, lead, and their compounds)

  • PFAS

• Priority risk-reduction substances: These are less hazardous but require proper handling to reduce the risk of unnecessary exposure. Criteria for priority risk-reduction substances can be found here.

PFAS in PRIO

The list of PFAS substances in PRIO should not be considered as an exhaustive inventory of all PFAS substances found worldwide, but it contains nearly 11,000 PFAS substances that are consistent with the OECD's 2021 definition of PFAS. The list of PFASs in PRIO can be downloaded here.

The OECD's definition of PFAS was also used in the EU’s PFAS restriction proposal to ban the manufacture and sale of PFAS in the EU, which was submitted to the European Chemicals Agency (ECHA) by Sweden, Denmark, Norway, Germany, and the Netherlands in February 2023.

On 15 November 2023, the European Chemicals Agency (ECHA) published a news report that identifies areas where research is needed to protect human health and the environment. The report entitled "Key a...

On 15 November 2023, the European Chemicals Agency (ECHA) published a news report that identifies areas where research is needed to protect human health and the environment. The report entitled "Key areas of regulatory challenges” also highlights areas where new methods are needed to support the move away from animal testing.

Background

The implementation of the Chemicals Strategy for Sustainability (CSS) calls for ECHA to review its advisory role on the issues where it can provide the most valuable input. Therefore ECHA has started to map its Key Areas of Regulatory Challenge (KARC) as part of the European Partnership for the Assessment of Risks from Chemicals (PARC) project.

The PARC project is a seven-year EU-wide research and innovation project that aims to advance research, share knowledge, and improve skills in chemical risk assessment. ECHA’s role in PARC is to ensure that the scientific research funded addresses current challenges in chemical risk assessment and adds value to EU regulatory processes.

Priority areas for research

In order to improve chemical safety in the EU, it is essential that scientific research provides data relevant to the rregulation of chemicals. ECHA has identified the following priority areas for research to improve the regulatory relevance of scientific data.

• Protection against the most harmful chemicals. Hazard identification for critical biological effects for which specific and sensitive test methods are currently lacking, i.e. developmental and adult neurotoxicity, immunotoxicity and endocrine disruption.

• Addressing chemical pollution in the natural environment. Key areas include bioaccumulation, extending biodiversity protection, and exposure assessment.

• Moving away from animal testing. Development of New Approach Methods (NAMs) to facilitate reduction of animal testing for read-across under REACH, move away from fish test to determine fish toxicity, and mechanistic support for toxicology studies e.g. carcinogenicity).

• Improve the availability of chemical data in particular for polymers and nanomaterials.  Development of analytical methods to ensure proper assessment of hazardous substances.

Mike Rasenberg, ECHA’s Director of Hazard Assessment, emphasised the urgency of aligning scientific research with regulatory needs "ECHA believes that to achieve the ambitions of the European Green Deal and the EU’s Chemicals Strategy for Sustainability we need more scientific research with regulatory relevance." He added: "There is a growing need for new test methods that do not rely on animals, and a better understanding of the toxicological mode of action of certain hazardous chemicals. Generating the necessary data without animal testing while protecting health and the environment cannot be achieved without scientific progress."

 The full text of the report is available here.