REACH-REFIT Evaluation - Dr. Roger Pullin (CIA/ECEG) SSDC European Chemical Industry, 24 February 2017

Chemical Industries Association (CIA) Represent UK chemical and pharmaceutical businesses Members: multinationals, as well as many other companies of all sizes including SMEs Chemical and pharmaceutical industry is one of the UK’s largest manufacturing export earners £15 billion of value to UK economy; leading manufacturing exporter generating trade surplus of £3 billion a year Sector employs around 500,000 people, paying 30% more than the manufacturing average with many jobs in the north of England and Scotland

REACH REFIT Evaluation consultation – CIA’s Response Online questionnaire + additional general comments submitted REACH is one of the key regulations the chemical sector and its supply chains have to comply with - the largest environmental regulation ever produced by the European Union From a chemical manufacturer’s point of view, CIA supports REACH in its aim to achieve better chemical management Companies as well as authorities are continuing to work hard on its implementation ….we are all still in a learning phase as mentioned by Erwin…

REACH REFIT Evaluation consultation – CIA’s Response New information on chemicals triggered by registration has made businesses better informed to understand controls needed, resulting in improved risk management More awareness amongst businesses outside chemical sectors Greater understanding of the presence of chemicals and their contributions to everyday life amongst general public By addressing the key issues related to chemical management, REACH works as it stands - it should not be reopened as a whole REACH substantially improving protection workers, environment, consumers and promoting level playing field across the EU Any potential shortcomings identified through the REFIT process should be addressed without reopening the main REACH core text.

REACH REFIT Evaluation consultation – CIA’s Response REACH unique in terms of complexity and number of substances as well as industries that it regulates. Unintended Consequences - ‘Drain on resources’ Compliance process proved very challenging and expensive Huge impact on resources for companies of all sizes, way above what was anticipated Administrative, legal issues, keeping up with IT developments, guidance changes as part of companies day-to-day activities  With regards to next steps, CIA asks the COM to be mindful on the impacts on company resources, and prevent wherever possible any unnecessary additional burden One question in the public consultation was on identifying potential unintended consequence of REACH. Next steps should be justified on risk-based science When it comes to its practical implementation, the compliance process has proved very challenging and a drain on resources for companies of all sizes, way above what had been anticipated. Overall, companies have experienced extremely high costs of compliance. Working in SIEFs has been a very complex, expensive and time consuming experience so far. Apart from focussing on the scientific, technical and safety aspects required for the preparation of registration dossiers and their maintenance, regulatory affairs and technical staff within companies have to also deal with administrative and legal issues as well as keep up with IT developments and guidance changes as part of their day-to-day activities. Beyond registration, other requirements including reacting to any request from the Agency on evaluation and updating dossiers, maintaining safety data sheets, monitoring developments on substances of very high concern and, for some companies, even seeking authorisation and complying with restrictions are contributing to a huge impact in terms of resources on companies. These are important aspects of REACH compliance today and will continue to be in future, beyond 2018.

REACH REFIT Evaluation consultation – CIA’s Response Impact on Competiveness & Innovation Anecdotally heard some substances already eliminated from product portfolios Unclear at present to what extent REACH is effectively promoting development of new, safer substances and therefore contributing to enhance competitiveness and innovation Commission’ plans to assess impact of the authorisation process on industry may prove helpful in this respect Aware COM is to launch a new study looking at authorisation impacts on industry and we’re happy to feed into this with support from our member companies. Example of nanoforms and need for grouping and read-across.

REACH REFIT Evaluation consultation – CIA’s Response On RMO Support the Risk Management Option (RMO) approach - Crucial step in supporting the decision making process for identify the right risk management route to be taken Identifying right RMO at early stages of selection process should continue & be strengthened to reduce uncertainty Substances should only be added to the Candidate list if the RMO analysis concludes that authorisation is most appropriate On a case-by-case basis, other risk management measures applied under REACH & other EU legislation may already provide for adequate control, including worker protection legislation Consideration to uses of a given substance needs to be at the earliest stage of the RMO process Online survey also asked about RMO in context of coherence. Hear others would like the COM to abandon.

INDUSTRY welcomes Commission’s recognition on: REACH & OSH In CIA’s response… INDUSTRY welcomes Commission’s recognition on: Need for common understanding of the two limit-setting systems for inhalation exposures (OELs and DNELs) Ensuring proper communication between ECHA and SCOEL INDUSTRY needs efficient mechanisms and procedures

HAS THE COMMISSION PROGRESSED FURTHER ITS THINKING? REACH & OSH cont. OSH-REFIT Evaluation (24 Directives) 3 priorities : carcinogens, helping businesses, ‘clean-up’ Overall Conclusion: “fit for purpose” + “some improvements“ Conclusion [Staff Working Document]: “Coexistence of national OELs and DNELs, which are communicated in the SDS, needs further clarification for employers with regard to the limit values they must take into account in the risk assessment and defining appropriate risk management measures” Recommendations/options HAS THE COMMISSION PROGRESSED FURTHER ITS THINKING?

Thank You Contact: Dr Roger Pullin Head of Health Chemical Industries Association Kings Building, Smith Square London, SW1P 3JJ Tel. 020 7963 6738 / Mob. 07951 387 317 Email: pullinr@cia.org.uk CIA’s Position: http://www.cia.org.uk/OurWork.aspx