From the Sector

The transition towards safer and more sustainable chemicals is progressing in some areas, while in others, it is just beginning. This is the finding of a first, joint Europe-wide assessment of the drivers and impact of chemical pollution by the European Environment Agency (EEA) and the European Chemicals Agency (ECHA). The benchmarking found that more work is still needed to reduce the impact of harmful substances on human health and the environment.

The number of industrial chemicals scrutinised under the EU’s chemicals legislation to determine their safety has increased substantially. Authorities now have much better knowledge about the hazardous properties of chemicals that are used across the EU, resulting in many actions to minimise and control the risks of several groups of substances.

According to the joint EEA-ECHA synthesis report on the EU indicator framework for chemicals, the overall use of the most harmful chemicals (in particular those that are carcinogenic, mutagenic and reprotoxic) is still growing but more slowly than the overall chemicals market growth. Pressure is increasing to avoid the use of so-called substances of concern and to implement the principles of the safe and sustainable by design framework.

There is a need to more effectively ensure that consumer products do not contain the most harmful substances, for example chemicals that are endocrine disrupting, that negatively affect the hormone system, or substances that are persistent, bioaccumulative and toxic, which present a risk for years to come even after their use has ceased.

More data and information are needed to better understand human and environmental exposure to those most harmful chemicals and their impacts. Still, the indicators show clearly that the shift to safe and sustainable chemicals must continue and should even be accelerated.

The report is based on a set of 25 key indicators, which monitor the drivers and impacts of chemical pollution in Europe.

Key findings

• Transition towards safer and more sustainable chemicals is progressing in some areas while in others it is just getting started.
• Action by authorities and industry has supported minimising and controlling the risks from several groups of hazardous chemicals. Efforts are ongoing to increase knowledge on chemical hazards and support risk management action where needed.
• Available data suggest that there is little evidence of progress towards eliminating substances of concern from waste and secondary materials. This is a barrier to the transition towards a more circular economy.
• Emissions of certain chemicals to water and air have fallen following specific EU regulations (e.g., on industrial emissions) and international actions, but further measures are needed to reach concentration levels that are not harmful for human health and the environment.
• Emissions from industry still lead to major costs in terms of damages to human and ecosystem health.
• Human biomonitoring offers the opportunity to understand human exposure to chemicals from multiple sources and thus health risks associated with chemical pollution. As such, biomonitoring forms a key tool to measure the effectiveness of chemicals legislation in protecting human health and the environment.

The European Chemicals Agency (ECHA) has published its Strategy Statement 2024-2028. The strategy details the agency’s goals and priorities over the next five years to protect health and the environment through its work for chemical safety.

Main elements of the Strategy – Goals and Priorities

Be a trusted chemicals agency – ECHA aims to achieve this by delivering its legal mandate using independent expertise and robust data. The Agency, to support this, will:

• Deliver transparent, independent, and high-quality scientific advice, opinions, and decisions;
• Enhance decision and policy making through optimal use of data, knowledge, and competence; and
• Facilitate the prioritisation and co-ordination of regulatory actions on substances and groups of substances with the European Commission (EC), EU agencies and Member State Authorities.

 
Respond to emerging challenges and changes in their legal landscape – ECHA will prepare for new tasks and inform EU chemical and environmental policy. To support this goal, it will focus on the following priorities:

• Implement new legal requirements using existing and new synergies and experience;
• Work with relevant EU agencies and bodies to deliver Chemical Strategy for Sustainability (CSS) actions and objectives; and
• Provide scientific and technical advice on chemicals to EU policy makers.

 
Communicate and Engage – by collaborating with stakeholders and partners, ECHA will strengthen public confidence in chemicals regulation. In support of this goal, the Agency will:

• Deepen their network of engagement with EU institutions and agencies and Member States;
• Collaborate and provide tools, advice, and support to industry; and
• Promote awareness and understanding of ECHA's work to stakeholders representing workers, the public and the environment.

 
Lead on chemical knowledge and expertise – the Agency will advance knowledge and understanding on chemical safety. To achieve this, it will:

• Contribute proactively to expanding scientific and technical competence and knowledge on chemical safety;
• Promote the development and use of alternative methods for the assessment of hazards and risks of chemicals; and
• Support the EC to enhance engagement and synergies at international level.

 
Invest in people and organisational excellence – ECHA is committed to working together to achieve their vision. In order to achieve this they will:

• Develop and empower their people for success;
• Create optimal ways of working for the Agency, its bodies, its people, and the environment; and
• Adopt an IT delivery model that is cost-effective, streamlined, modular, interoperable, cloud based and centralised.

The European Chemicals Agency (ECHA) has added five new chemicals to the Candidate List. One of them is toxic for reproduction, three are very persistent and very bioaccumulative and one is toxic for reproduction and persistent, bioaccumulative and toxic. They are found in products such as inks and toners, adhesives and sealants and washing and cleaning products.

The Agency has also updated the existing Candidate List entry for dibutyl phthalate to include its endocrine disrupting properties for the environment.

ECHA’s Member State Committee has confirmed the addition of these substances to the Candidate List. The list now contains 240 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.

The European Chemicals Agency (ECHA) has published a new report on ‘Key areas of regulatory challenge 2023’ that identifies areas where research is needed to protect people and the environment from hazardous chemicals. It also highlights where new methods, that support the shift away from animal testing, are needed.

To further improve chemical safety in the EU, scientific research needs to deliver data that is relevant to regulating chemicals. In order to enhance the regulatory relevance of scientific data, ECHA has identified the following areas as priorities for research:

• Hazard identification for critical biological effects that currently lack specific and sensitive test methods: i.e. developmental and adult neurotoxicity, immunotoxicity and endocrine disruption
• Chemical pollution in the natural environment (bioaccumulation, impact on biodiversity, exposure assessment)
• Shift away from animal testing (read across under REACH, move away from fish testing, mechanistic support to toxicology studies e.g. carcinogenicity)
• New information on chemicals (polymers, nanomaterials, analytical methods in support of enforcement)

Background
The European Partnership for the Assessment of Risks from Chemicals (PARC), is a seven-year EU-wide research and innovation programme under Horizon Europe which aims to advance research, share knowledge and improve skills in chemical risk assessment.

ECHA’s role in PARC is to make sure that the funded scientific research addresses current challenges related to chemical risk assessment and adds value to the EU’s regulatory processes.

The key areas of regulatory challenge report can be seen as an evolving research and development agenda aiming to support and inspire the Partnership for the Assessment of Risks from Chemicals (PARC) and the wider research community. The list of research needs is not exhaustive. The next update to the report is expected in spring 2024.

The European Chemicals Agency invites interested parties to send in scientific and technical information on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) by 25 September 2023.

The six-month consultation on the restriction proposal, prepared by the Danish, German, Dutch, Norwegian and Swedish authorities, opens on 22 March 2023 and closes on 25 September 2023 (23:59 Helsinki time).

The consultation is to give anyone with information on PFAS the opportunity to have their say. Of particular interest is information relevant to the risks, socio-economic aspects and alternative substances.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the consultation input to evaluate the proposed restriction and form an opinion on it.

An online information session will be held on 5 April. During the session, experts from ECHA and the five national authorities will explain the restriction process, the content of the proposal and how to participate in the consultation. They will also respond to questions from the participants.

The five national authorities submitted the universal proposal to restrict PFAS to ECHA on 13 January. The European Commission, together with the EU Member States, will eventually decide on the potential restriction based on the proposal and the committees’ opinion.

ECHA has added nine chemicals to the Candidate List because of their hazardous properties. They are used for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers and in the manufacture of textile, leather or fur and paper.

Entries added to the Candidate List on 17 January 2023:

• 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]
• 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol
• 4,4'-sulphonyldiphenol
• Barium diboron tetraoxide
• Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
• Isobutyl 4-hydroxybenzoate
• Melamine
• Perfluoroheptanoic acid and its salts
• reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine

Information on these substances' uses and reasons for inclusion on the Candidate List is available here.

Archroma announced the launch of EARTH SOFT, a new softening system for textile and fashion applications, based on Archroma's latest innovation, a vegan silicone softener, Siligen® EH1, with 35% plant-based active content.

Siligen® EH1 is the latest addition in the plant-based innovations developed by Archroma in recent years, such as EarthColors® dyes and Appretan® NTR binders, as alternatives offered to manufacturers and brands looking to reduce the use of fossil fuel based ingredients without compromising performance.

The range has been developed in line with the principles of “The Archroma Way to a sustainable world: safe, efficient, enhanced, it’s our nature”. More than 35% of the Siligen® EH1 softener's active content is based on plant-based, renewable raw materials. In addition, the product features ultralow cyclic siloxanes (D4, D5, D6) which are classified by the European Chemicals Agency as “Substances of Very High Concern” due to their very persistent and bioaccumulative properties.

Siligen® EH1 is ideally suited for shirts, underwear, sportswear, towels, bed sheets, etc. as it provides an excellent wearing comfort by supporting a good moisture transportation and delivering a smooth and soft touch.

The new softener, and the EARTH SOFT system which also includes a Hydroperm® wicking agent to boost hydrophilic properties on synthetic and blended fibers, can be applied on all natural and synthetic textile fibers.

Siligen® EH1 is suitable for both woven and knitted articles. It can be applied by padding process, as well as by exhaust process as it shows a very good shear stability and a low foaming profile. It can be used on white articles and those treated with optical brighteners, as it doesn’t cause thermomigration nor phenolic yellowing.

Paul Cowell, Head of Competence Centers for Brand & Performance Textile Specialties at Archroma, comments: “The new EARTH SOFT system based on Siligen® EH1 softener adds to our growing portfolio of innovations based on natural and renewable plant-based resources. This new breakthrough innovation by Archroma helps us and our partners in the textile and fashion industry to minimize our dependence on petroleum fossil fuel products.”

Some of the newly added substances are used in consumer products such as cosmetics, scented articles, rubber and textiles. Others are used as solvents, flame retardants or to manufacture plastics products. Most have been added to the Candidate List because they are hazardous to human health as they are toxic for reproduction, carcinogenic, respiratory sensitisers or endocrine disruptors.

Companies must follow their legal obligations and ensure the safe use of these chemicals. They also have to notify ECHA under the Waste Framework Directive if their products contain substances of very high concern. This notification is submitted to ECHA’s SCIP database and the information will later be published on the Agency’s website.

Background
The Candidate List includes substances of very high concern that may have serious effects on our health or the environment. These substances may be placed on the Authorisation List in the future, which means that companies would need to apply for permission to continue using them. The Candidate List has now 219 entries – some of these cover groups of chemicals so the overall number of impacted chemicals is higher.
 
Under the REACH Regulation, companies may have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List. Any supplier of articles containing a Candidate List substance above a concentration of 0.1 % weight by weight has to give sufficient information to their customers and consumers to allow safe use.
 
Importers and producers of articles containing a Candidate List substance have six months from the date of its inclusion in the list (8 July 2021) to notify ECHA. Suppliers of substances on the Candidate List (supplied either on their own or in mixtures) have to provide their customers with a safety data sheet.
 
As of 5 January 2021, suppliers of articles on the EU market containing Candidate List substances in a concentration above 0.1% weight by weight must notify these articles to ECHA’s SCIP database. This duty comes from the Waste Framework Directive.
 
More information on these obligations and related tools are available here.