[Introduction] [Generation of new hazard data] [Regulation of groups of chemicals] [Mixtures] [New Hazard Classes] [Restrictions on marketing of hazardous chemicals] [Enforcement] [Sustainability] [Worldwide] [References]

Chemical regulations are undergoing a revolution.

This post informs you of EU and global changes to chemical regulation, based on recent proposals by the EU Commission and the United Nations. EU Regulation is expected to become the Gold Standard which will be influence chemicals policy in other countries. These radical proposals will compel industry to produce safer products, eliminate hazardous substances, and improve sustainability.

If you wish to find out more about what we offer check out our services or contact us. For help with the jargon, see our glossary.

Introduction

Companies need to move on from ‘business as usual’ to survive the changes that are coming.

Chemical regulators recognises the harms that chemicals pose to consumers, workers, people exposed via the environment, and wildlife.

These concerns are that:

• Hazardous chemicals are released into the environment in large quantities, which would continue to increase with ‘business as usual’
• Chemicals, including some pesticides, heavy metals, plasticisers and flame retardants, are ubiquitous in the environment and accumulate in humans
• Chemicals contribute to the burden of disease in humans, with vulnerable populations at particular risk, eg from cancers, and hormone and reproductive effects
• In the environment, chemicals lead to degradation of ecosystems and loss of biodiversity, eg loss of pollinator insects
• Environmental chemical contamination is a legacy issue which will be passed to future generations.

There is a hugely ambitious programme of regulation to tackle these issues. The UN, with 193 member states, has issued a Global Chemicals Outlook [1] to provide goals and the direction of travel for chemicals policy.

The EU Chemicals Strategy [2] has reinforced and enhanced the UNs goals to include:

• A toxic-free environment through pollution reduction
• Chemical sustainability through promotion of circular economy.

This Strategy balances the value of chemicals to society with the harms they can cause, and to planetary boundaries from use of natural resources. It also responds to consumer demand for a high level of protection from hazardous chemicals.

Overall, the strategy steers industry to produce safe and sustainable products. Stringent regulation will produce winners and losers in the chemical industry. It is a recognised challenge for smaller chemical companies to adapt to a quickly changing regulatory environment.

EU regulators say that stricter chemical regulation has overall benefits. A reduction in exposures would be cost-effective in terms of reducing disease, particularly cancers, and environmental degradation.

The main policy areas are given below and indicate the direction that chemical companies need to take. Companies need to move on from ‘business as usual’ to survive the changes that are coming.

It is a recognised challenge for smaller chemical companies to adapt to a quickly changing regulatory environment.

Generation of new hazard data

The REACH Regulation [3] launched in 2007, was seminal in generating hazard data on 22 000 chemical substances. Chemical companies were obligated to provide a registration dossier to the European Chemicals Agency (ECHA) under the ‘no data, no market’ principle (REACH Regulation, Article 5).

Thanks to this regulatory strategy, ECHA has the most comprehensive database on chemical hazards and uses.

Non-confidential information in the chemicals database is freely available on the ECHA website [4]. Note that you may need permission from the data owner before using the data for commercial purposes.

However, some chemicals are exempt from registration requirements, and the EU Commission proposes that industry generates data for the following:

• Polymers: Proposal to extend the registration requirement to some polymers, with data requirements proportionate to the level of concern [5].
• Low tonnage substances. For substances registered at 1 to 10 t, proposal to increase the information needed (in REACH Annex VII), and require a Chemical Safety Report for CMRs, Category 1A or 1B.

Regulation of groups of chemicals

The generation of data substance-by-substance is costly to industry. Also, the EU Authorities regard the process as inefficient with respect to regulating hazardous chemicals. By the time some highly hazardous substances have been banned or restricted, they have been replaced on the market by chemically similar, but as yet unregulated substance (so-called regrettable substitution).

Another approach in the EU Chemicals Strategy is to evaluate the hazards of groups of substances based on chemical structure.

Industry has used grouping of substances to reduce the overall amount of testing required for REACH registration, where the hazards of each member of the group can be predicted on the basis of common chemical features (using so-called read-across of data). A high level of proof is needed to show that that the grouping and read-across are scientifically valid.

The EU authorities are considering a similar grouping approach when taking regulatory decision on restricting or banning substances. They will assume a hazard belongs to a whole group of chemicals with a particular structural feature, and regulate the group as a whole.

Polyfluoroalkyl substances (PFASs) are a noteworthy group of chemicals where substance-by-substance regulation has failed to protect health and the environment. PFASs are now expected to be regulated as a group of 10 000 related substances [6].

Industry’s concern is that the level of proof for chemical similarity will be lower in these cases than it is for industry, leading to marketing restrictions on safe and useful chemicals.

Mixtures

The REACH Regulation requires data collection and risk assessment for substances.

Specialist EU regulations for cosmetics, plant protection products, and biocides require assessment of the final mixture.

However, these assessments examine the substance or mixture in isolation. EU Authorities are concerned about the effect of exposure from:

• The same chemical substance from different product sources
• Different chemical substances with similar hazards providing a cumulative or synergistic effect (chemical-cocktail effect).

EU Authorities have regarded evaluation of chemical mixtures as impossible, due to the infinite combinations of chemicals, exposure, and timeframes.

To tackle the concerns, the Chemicals Strategy introduces a ‘mixture assessment factor’ into the chemical safety assessment (CSA) of substances.

The CSA is a risk assessment carried out during the REACH registration process (see our previous post for more detail). During the CSA, assessment factors are used to adapt test data, often high-dose animal tests, to safe doses for workers, consumers, wildlife, etc. For example, a Derived-No-Effect Level (DNEL) for an 8 h work shift can be calculated from a no-observed-adverse effect level (NOAEL) in a repeated-dose study in rats, using assessment factors accounting for differences in species, weight, size, etc between the test species (rats) and the target species (humans).

The mixture assessment factor may be applied during the derivation of the safe limits (DNELs, PNECs), or to the final risk characterisation ratio. In either case, the additional safety factor would require industry to further reduce exposures to harmful chemicals, for example by installing efficient ventilation or water-treatment systems, thus driving the chemical industry to safer chemical management.

There is current debate on the size of the mixture assessment factor, and whether it should be restricted to substances with the most serious hazards.

New Hazard Classes

The EU CLP Regulation (1272/2008) [7], based on the UN GHS [8], gives the rules for hazard classification of chemicals. This process allows simple codification of the potential harms of chemical products. For example, Flammable Liquid, Category 3 indicates a liquid with a flash point between 23 and 60 °C.

See our guides to classification for substances and mixtures.

As noted in our Compendium of Chemical Hazards, the CLP hazard classification does not cover all potential harms from chemicals.

A new Regulation [9] extends the hazards that are covered by the CLP Regulation, including the following new Hazard Classes:

• Endocrine disruptor for human health (ED HH) (Categories 1 and 2)
• Endocrine disruptor for the environment (ED ENV) (Categories 1 and 2)
• Persistent, bioaccumulative and toxic (PBT)
• Very persistent, very bioaccumulative (vPvB)
• Persistent, mobile and toxic (PMT)
• Very persistent and very mobile (vPvM)

Endocrine disruption as a separate Hazard Class has been controversial, because it is based on the mechanism by which the adverse effect occurs, ie through hormone-mediation. Often the adverse effect would be covered by another Hazard Class, eg reproductive or developmental toxicity, carcinogenicity, or STOT-RE.

We explained endocrine disruption in an earlier post, and more detail of the endocrine disruptor classification is given here.

PBT and vPvB assessment has been part of the REACH obligations for years. These Hazard Classes identify substances that are long-lasting in the environment, and can accumulate in wildlife and humans. They are persistent organic pollutants that are included in the EU Candidate List of Substances of Very High Concern (SVHC).

PMT and vPvM are new Hazard Classes designed to address environmental problems caused by long-lasting, mobile chemicals such as polyfluoroalkyl substances (PFASs).

The EU has regulated for these hazards before they have been incorporated into the international UN classification system (GHS). The EU Commission in its Chemicals Strategy demands robust and urgent regulation of SVHCs, as covered by these new Hazard Classes, and they were not prepared to delay until the UN agreed criteria.

Further details of these new hazard classes are given in an earlier post.

Restrictions on marketing of hazardous chemicals

Another key route to the ‘toxic-free environment’ is restriction on marketing of the most hazardous substances.

EU authorities have voiced frustration at the slow progress of regulations in removing hazardous substances from supply chains. Speedy regulatory action is seen as a key element in the process of driving innovation to safer chemical products, particularly for consumers.

Mandatory disclosure of hazardous chemicals in products allows consumers to protect themselves, eg from skin sensitising agents to which they may be susceptible, but also to shape market demand for safer and more sustainable products.

The REACH Regulation has criteria for identifying chemicals with the most serious hazards, ie carcinogens, reproductive toxicants, and environmentally persistent substances. These are listed in the Candidate List of Substances of Very High Concern (SVHC) and are subject to the Authorisation process and restrictions in marketing.

The Strategy foresees that for these SVHCs, and other substances with serious hazards, use will be minimised and they will be substituted as far as possible by safer alternatives. Only-essential uses, where substitution is not possible, will be allowed, and this will require more justification. The EU Commission needs to develop the criteria for essential use, considering the goals of a toxic-free environment and sustainability.

EU Authorities cites the successful reduction in the exposure of consumers to carcinogens as a model of good regulation. The reduction has been effected by a ‘generic approach to risk management’, whereby protection measures are triggered as soon as the substance is identified with a certain hazard, eg the restriction on marketing of CMR substances, as listed in Annex XVII of the REACH Regulation, in consumer products (Annex XVII, entry 28).

This approach to risk management bypasses the lengthy Authorisation process (see previous post) whereby individual substances are assessed based on a socio-economic analysis of the risks and benefits of using the substance. The generic approach is expected to become the default option, particularly for substances used in consumer products, and will likely be extended to chemicals affecting the endocrine, immune, neurological or respiratory systems, or a specific organ (STOT), and persistent or bioaccumulative substances.

Enforcement

Enforcement by authorities helps conscientious companies, by penalising other companies that avoid the cost of regulatory compliance.

Safety data sheets

Safety data sheets have long been criticised for containing poor information on the safe handling of the product they describe [10].

The main issues of quality relate to:

• The emergency telephone number in Section 1
• Incorrect classification in Section 2, especially when compared to concentration ranges of components for mixtures in Section 3
• Missing national occupational exposure limits
• Missing information provided on control measures in Section 8, including specific details on personal protective equipment (PPE).

Under a new enforcement project [11], EU Member State enforcement authorities will check the quality of SDSs and compliance with the new EU standard for SDSs (REACH Regulation, Annex II, as updated by Regulation 2020/878 [12]).

For details of the EU SDS formatting see our Safety Data Sheet Contents Guide.

REACH registration dossiers

Another long-standing criticism is that REACH registration dossiers do not contain the information specified in the legislation, either because they never did, or because they have not been updated when new information became available. ECHA estimates that only one third of the registration dossiers of the chemical substances registered by industry are fully compliant.

The problem arose because ECHA did not have the resources to check every dossier submitted in the REACH transition period (2012 to 2018) before issuing the registrant with a registration number. The supplier uses the registration number to show that its product complies with the REACH Regulation, and is communicated in the supply chain, for example in the SDS. It is currently not within ECHA’s power to revoke registration numbers for non-compliant registration dossiers.

In the Chemicals Strategy, the EU Commission intends to strengthen the principles of ‘no data, no market’ (REACH Regulation, Article 5) by requiring compliance of all registration dossiers and revoking the registration numbers in cases of persistent non-compliance.

Sustainability

The move to a sustainable, circular economy requires some unpalatable measures for chemical manufacturers and suppliers

Chemicals production is an energy- and carbon-intense sector, often based on hydrocarbon or mining operations. Future chemical strategy will drive the chemical industry towards more sustainable production through a circular economy based on recycling of chemicals and articles that contain them.

The main issues of chemical sustainability are:

• Chemical manufacture is wasteful, often creating more waste than product
• Many durable articles such as building materials and machine parts contain hazardous chemicals which impedes recycling, especially if the chemical content is unknown
• Products containing hazardous chemicals are not designed for recycling
• Hazardous chemicals may persist for years, particularly in articles, creating potential future legacies.
• Ca. 9 per cent of the 6.3 billion metric tons of plastic waste has been recycled, while 12 per cent was incinerated, and 79 per cent was disposed in landfills or in the environment.

As well as requiring less natural resources, a circular economy is expected to require less energy and lower emissions to the environment.

The move to a sustainable, circular economy requires some unpalatable measures for chemical manufacturers and suppliers:

• Full ingredient disclosure of products to the supply chain in order to facilitate recycling of finished goods
• More transparency in disclosing hazardous ingredients to consumers, perhaps through additional labelling information, allowing them to make informed choices
• Implementation of recycling and waste management systems
• Research and implementation of sustainable product, eg in elimination of hazardous chemicals and use of recycled raw materials while maintaining product quality
• Strict regulation concerning chemical content of products, particularly for consumer products such as textiles and cosmetics
• Increase in enforcement activities for companies exporting to the EU, particularly those that are delivered directly to consumers.

The EU Chemicals Strategy sees people power as a key driver for sustainability. If products list hazardous ingredients on the label or through computer apps, then consumers will use their purchasing to shape the market for safer and more sustainable products.

EU consumers are at risk from products that do not show the hazards of the product or the hazardous ingredients at the point of sale, particularly for purchases made online and for imported articles containing harmful chemicals. Such products from outside the EU, may have been manufactured under less rigorous regulation and not comply with EU requirements. While EU Authorities have no jurisdiction over non-EU companies, stricter enforcement policies at the border would level the playing field for EU suppliers.

Worldwide

EU industry complains that strict EU regulation drives production out to less regulated countries. Whether or not regulations are to blame, global chemicals production is estimated to double in the coming decade while the global share of the EU chemical industry is expected to shrink, and chemical production will shift to developing countries.

The EU is a world leader in regulatory management of chemicals, and EU will advocate safe and sustainable-by-design strategies on the international stage in order to promote safety and reduce global wastes and pollution. Increasing chemical management in developing countries would level the playing field for EU companies. The EU authorities intend to share data and know-how to ensure that problems of chemical harms are not simply exported.

There would be benefits to industry from globalised regulation, particularly in mutually acceptance of chemical hazard data, risk assessments and classifications. Companies complying with EU regulation would find registration in other jurisdictions simpler, giving access to more markets.

The UN GHS has been a great success in harmonising the hazard classification criteria for chemicals, and also the formatting and information requirements for safety data sheets and product labels.

Regrettably, there is no international database of hazard classifications for particular chemicals. Several countries have created classification databases, using their own interpretation of hazard data and the classification criteria. This has led to discrepancies in hazard classification of the same chemicals in different countries. Some details of classification inventories are given in our earlier blog Can you author a safety data sheet or product label for worldwide use?

The EU Chemicals Strategy voices an intention to pursue a worldwide hazard classification inventory, although this would be a difficult process not that national inventories have become well-established.

References

[Back to Introduction] [Back to Generation of New Hazard Data] [Back to Regulation of groups of chemicals] [Back to New Hazard Classes] [Back to Enforcement]

[1] Global Chemicals Outlook II: summary for policymakers; United Nations Environment Assembly; 21 January 2019.

[2] Chemicals Strategy for SustainabilityTowards a Toxic-Free Environment; COM(2020) 667 final; 14 October 2020.

[3] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (as amended).

[4] Search our data at https://echa.europa.eu/

[5] An initial thought starter on REACH information requirements for Unique Polymers Requiring Registration; Brussels, 15 March 2021 CASG-polymers 02/2021.

[6] Registry of restriction intentions until outcome; Per- and polyfluoroalkyl substances (PFAS); https://echa.europa.eu/.

[7] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (as amended).

[8] Globally Harmonized System of Classification and Labelling (GHS); Ninth Revised Edition; United Nations; 2021.

[9] Commission Delegated Regulation (EU) 2023/707 of 19 December 2022; as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.

[10] Report on Improvement of Quality of SDS; ECHA; Version 1.0; 16.05.2019.

[11] Forum Working Group; Work Package A.1; Coordinated enforcement project REACH-EN-FORCE-11.

[12] Commission Regulation (EU) 2020/878 of 18 June 2020 amending Annex II to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).