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

2. 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

3. 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…

4. 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.

5. 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.

6. 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.

7. 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.

8. 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

9. 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?

10. Thank You Contact: Dr Roger Pullin Head of Health
Chemical Industries Association
Kings Building, Smith Square
London, SW1P 3JJ
Tel / Mob
CIA’s Position: