Report on the operation of REACH and CLP 2021

 

ECHA’s five-yearly report on the operation of REACH and CLP presents a detailed picture on how the operations have impacted worker and consumer health, environmental protection, innovation, competitiveness and internal market functions. It also highlights that challenges remain and the findings will be used to inform the Commission in their general assessments of REACH and CLP in the coming years.

 

Europeans remain concerned about the impact that chemicals in the products they use have on the environment and on their health. To address these concerns, the policy context has been rapidly evolving in the last five years. The European Green Deal has set goals to better protect human health and safeguard the environment as part of its ambitious approach on zero pollution and moves towards a toxic-free environment.

As the Agency coordinating the implementation of activities under the REACH and CLP Regulations, ECHA is in a unique position to report on their operation and impact, where their functioning could be improved and to provide a fact base to support policy developments to move Europe forward in its pursuit of safer and more sustainable chemicals.

Using data available to ECHA, the report connects the activities under REACH and CLP to their outcomes and assesses how far these have translated into impacts. The report also reflects on the operation of the two regulations, their strengths, and issues that should be addressed in the upcoming review.

Impacts achieved through outcomes from duty holders’ and authorities’ activities Higher protection of human health and the environment Better functioning of the internal market Increased competitiveness and innovation Promotion of alternative methods to animal testing Improved information exchange across the supply chain Improved transparency on substances and their use Increased R&D and business opportunities for substitution Increased predictability and market trust for market players Improved knowledge on substances and their uses Restrictions on the use of hazardous substancesConditions imposed when the use of an SVHC is authorisedSubstances identified as CMR, endocrine disruptor, PTB/vPvB or sensitisersChemical safety assessments by industry for all 5 000 higher-volume hazardous substances, safe use conditions determined and communicatedHarmonised classificationSubstitution of SVHCsData gathered and shared by industry on 23 000 substances180 000 substances self-classified by industryHarmonised set of rules for all substances after the end of the phase-in scheme (2018)Fast market access if companies have the required data; no access if they do not Degree to which the outcomes are achieved, through compliance with the obligations Improved identification, control/restriction or substitution of hazardous substances Reduced exposure to hazardous chemicals Increased R&D and business opportunities for alternative testingAchievement of the "Three Rs" principle for animal testing (replace, reduce, refine)
Key messages

Over the last five years, the operations of REACH and CLP have advanced the protection of worker health, consumer health and the environment in the EU. They have also positively contributed to innovation, competitiveness and the functioning of the internal market within the EU.

Despite this, synergies between REACH, CLP and other legislation have often failed to materialise and much still needs to be done to achieve the levels of protection envisaged by the legislators.

 

 

Registration

The final deadline in 2018 was a milestone – as we now have more data than ever before on 23 000 most-used chemicals in Europe.

The registration obligation motivated companies to refocus, correct or strengthen their risk management.

Companies need to improve the information in their registrations as well as in the main vehicles for communicating safe use – chemical safety reports, safety data sheets and exposure scenarios, and classification and labelling.

 

 

Grouping and the Integrated Regulatory Strategy

The collaborative approach between ECHA, Member States and the Commission has accelerated the screening of registered substances and has sped up the assessment of whether more data generation risk management measures are needed.

Working with groups has become the norm in recent years and has helped to obtain a more complete picture of ‘the universe’ of registered substances – giving us a better idea of where action is needed. Almost 2 000 substances have been screened in 2020 alone.

The acceleration of compliance checks and actions under the Evaluation Joint Action Plan are helping to ensure that companies comply with the information requirements set in REACH. But substance evaluation has proven to be inefficient for clarifying concerns on priority substances.

 

 

Authorisations

As of December 2020, 386 substances of very high concern are on the Candidate List (grouped in 211 entries). For 54 entries, an authorisation is required for non-exempted uses; for 25 of these, all such use has ended.

ECHA has assessed over 200 applications for authorisation that have reported how European companies plan to substitute and reduce health and environmental risks.

Authorisation has been successful at reducing risk to workers, consumers and the environment, and there are clear indications that substitution has been achieved. However, it is not efficient, and in general information on available alternatives is lacking.

 

 

Restrictions

EU restrictions are working well, resulting in greater protection for workers, consumers and the environment. Thanks to the grouping approach, more substances – covering more uses – have been proposed to be restricted than in earlier years. For example, emissions to the environment from microplastics, siloxanes, and lead in shot are expected to reduce significantly if the proposed restrictions come into force.

Industry also generally complies with restrictions – more than 80 % of consumer products inspected by Member State inspectors comply with restriction obligations, with most incompliance in imported products.

 

 

Classification and labelling

The CLP Regulation provides a basis for hazard assessment and could play an important role in a ‘one substance, one assessment’ approach.

Through labels, CLP directly drives risk management for workers, consumers and the environment.

The Classification and Labelling Inventory contains information on around 180 000 substances self-classified by companies, but industry compliance is insufficient and there is still divergence in self-classifications for the same substance.

Member State inspectors have also found that one-third of labels for mixtures contain deficiencies – mostly related to incorrect or missing hazard statements.

A steady increase in the harmonised classification and labelling of carcinogenic, mutagenic and reprotoxic (CMR) substances (71 between 2016-2020) is expected to induce further risk management measures by employers to protect their workers from exposure to these chemicals at work.

The benefits of classification and labelling are further extended indirectly, with much of the EU’s chemicals legislation relying on CLP hazard assessment.

 

 

Internal market functioning

REACH provides fast access to the EU market and tighter actions by authorities have improved conditions for companies to compete without compromising on chemical safety.

Improved transparency on substances, their hazards and uses allows authorities, companies, workers and consumers to make better informed decisions on chemical safety.

The increased predictability of upcoming regulatory actions encourages greater market trust and ECHA’s website is the primary gate for access to such information.

 

 

 

Animal testing

The standard information requirements for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation were updated in 2016-17, making non-animal testing the default requirement under REACH.

ECHA’s latest report on ‘Alternatives to animal testing’, indicates that the included non-animal test methods have clearly been taken up by companies in their registrations.

 

 

Financing and Member State support

Despite a lot of progress since our previous report in 2016, further efforts are needed to ensure that REACH and CLP operate as intended.

For ECHA to continue to successfully perform its tasks under REACH and CLP, it needs a more sustainable financing mechanism.

Member States also need to step-up their contribution to the work of the ECHA committees and increase their capacity to perform their tasks under REACH and CLP, including enforcement.