UK Chemicals Stakeholder Forum – Annual Report 2015

UK Chemicals Stakeholder Forum (UKCSF)

Thirteenth Annual Report

2015

UK Chemicals Stakeholder Forum – Annual Report 2015

Contents Chairman’s Foreword

Background Chapter 1

The Forum in 2015 (59th – 62nd meetings)

Chapter 2

Key activities and outputs

A B C D E F

Forum Terms of Reference Forum members and attendance at meetings in 2015 Updated Forum Guidance on REACH Authorisation Forum Guidance on 2018 REACH Registration deadline 2015 Review of the UK Chemicals Stakeholder Forum

Financial information

UK Chemicals Stakeholder Forum – Annual Report 2015

Chairman’s Foreword

Once again time has flown by, as I bring you what is already my third annual report as Chairman of the UK Chemicals Stakeholder Forum. It has been a good year, and we have the prospect of more useful and interesting activity in 2016.

It is obvious that REACH takes up quite a bit of our time. I am therefore extremely glad that we have produced new Forum Guidance on the REACH 2018 Registration deadline. I am grateful to all the members who made this possible. I know that it has been well received, and that much effort has gone into sharing this Guidance more widely. We were also able to update our 2013 Guidance on that other pillar of REACH which is Authorisation. I have no doubt that the work we have done in these areas has helped others, and served to raise our profile with the wider community that takes an interest in our work, and I include in that the European Chemicals Agency. We will continue to share our work and engage widely.

Of course, the Forum is about more than REACH. In particular I very much welcome what the Forum is trying to do on the complex issue of sustainability. We are getting good input from outside the Forum for this work, and I am sure the Forum members themselves will want to do more on this.

I was also very pleased that we managed throughout 2015 to deliver a broad and stimulating programme of presentations to the Forum. These can really help to stimulate thinking and enable the Forum to cover a range of issues with key players.

I must once more thank the members for what they bring to the Forum. I am grateful to them for making my task easy. We all know that Defra expects value from the Forum but the members too should derive value from the Forum. The more members put in, the more they get out of the Forum, but all members must contribute to the best of their ability and resources.

As always, I must acknowledge the support I have had from the Forum Secretary and other officials from Defra, the UK REACH Competent Authority, and other Departments, who contribute so much to our meetings. These meetings would, of course, also not be the same without the valuable involvement of other interests, who attend as observers, or speakers, and who enrich our discussions and tell others about our work. They will always be welcome at our meetings.

We ended the year with a review of the Forum. It was encouraging to note that Defra was taking the view that the Forum should continue to exist but at the same time it is right to seek to improve its effectiveness. I look forward to the outcome of the review. Professor David Phillips Chairman April 2016

UK Chemicals Stakeholder Forum – Annual Report 2015

Background

The UK Chemicals Stakeholder Forum (UKCSF) was established in September 2000. Its principal function is to advise the Government on how industry should reduce the risks from hazardous chemicals to the environment and to human health through the environment. In addition, the Forum has an advisory role to Government on REACH, which is the main EU Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (adopted in December 2006).

It meets four times a year, and held its sixty-second meeting in November 2015. Forum meetings are open to the public, usually attended by the specialist press, and papers and minutes for the meetings are published on the Forum website at:

https://www.gov.uk/government/groups/uk-chemicals-stakeholder-forum

The Forum has an independent Chairman, and its membership is drawn from industry, environmental and animal protection and conservation non-governmental organisations, trade unions, and the scientific community. The broad and unique membership of the Forum ensures it is able to explore the views of the many sectors of society who work with, or are concerned about, industrial chemicals. The Department for Environment Food and Rural Affairs provides the Secretariat for the Forum which can draw on advice, and other support, from other Government Departments and bodies, in particular the Department for Business Innovation and Skills, the Health and Safety Executive (who are the UK REACH Competent Authority), and the Environment Agency. The Forum is also able to draw on scientific advice from the Hazardous Substances Advisory Committee.

The Forum’s work has changed in recent years. It no longer assesses chemicals of concern, as it used to do. This is partly due to the adoption and implementation of REACH; and to an increasing focus on the strategic objective of promoting sustainability in the chemicals supply chain.

The Forum’s terms of reference, membership and attendance at meetings for 2015 are listed at Annexes A and B.

UK Chemicals Stakeholder Forum – Annual Report 2015

Chapter 1 -The Forum in 2015 (59th – 62nd meetings)

Forum meetings were held in 2015 – on 27 January, 28 April, 14 July and 3 November. A high level summary of these meetings is provided below; more detail is available from the minutes, papers and presentations for the meetings, on the Forum website - https://www.gov.uk/government/groups/uk-chemicals-stakeholder-forum

27 January 2015 – 59th meeting

The REACH-related part of the meeting included the usual updates from Defra and UK REACH Competent Authority officials on various REACH aspects, reports of meetings in Brussels and Helsinki, consultations by ECHA and by the EU Commission. Forum members were interested in the UK response to the DG SANCO consultation on defining criteria for identifying endocrine disruptors. Other points raised included specific Authorisations and Restrictions, fair cost-sharing and alternatives to animal testing. Defra reported on the completion of phase 2 of its survey on the impacts of REACH on business.

The first presentation of the year was given by Anna Lennquist (from the Swedish NGO ChemSec, the International Chemical Secretariat, on its Updated SIN List, and its new associated screening tool. The presentation stimulated exchanges about hazard and risk-based approaches to chemical regulation.

Nick Boley gave a presentation on the Government Chemist advisory function on matters of interest to the UKCSF. He touched on the technical expertise and services of the Government Chemist which were available to regulators and to industry.

Susanne Baker outlined a work plan for the proposed Forum Guidance on the 2018 REACH Registration deadline. There were also plans for the sub-Group (on raising awareness of REACH with SMEs) which she chaired to update the existing Forum Guidance on Authorisation.

David Taylor launched the work of the new sub-Group on Sustainability, in particular the proposal to gather information on four sectors of the supply chain, namely Raw Material Supply, Chemicals Manufacture, Converters and Merchants. Initial thinking would focus on Resilience of Supply, Efficiency of Operation and Transfer of Information.

Richard Vincent reported on various areas of activity on international chemicals management, in particular on mercury and on the Strategic Approach to International Chemicals Management (SAICM).

Simon Marsh updated the Forum on the work of the Chemistry Growth Partnership.

Emma Stuart reported on the 9th meeting of the Hazardous Substances Advisory Committee which had taken place in December.

Patrice Mongelard signalled the Secretariat’s intention to produce an Information Sheet to provide the Forum with periodic updates on the OECD work on chemicals.

8 April – 60th meeting

UK Chemicals Stakeholder Forum – Annual Report 2015

The REACH updates were full and detailed, with discussion supplementing the papers which had been tabled. Issues which were raised included amongst others - test methods, ECHA fees and charges, on-going consultations, various proposed Restrictions, Authorisation applications in particular for lead chromates, REACH and nano-forms of substances, the European Court case on substances in articles, and the role and technical expertise of ECHA committees. Defra was able to report on the full findings of its survey on the impact of REACH on business.

The detailed work on the Forum Guidance on the 2018 Registration deadline had started and draft content, including proposed flow charts, was discussed by members.

There were three highly interesting presentations given in the course of the meeting. Harry Swan, Managing Director of Thomas Swan & Co, told the Forum about the work which the Chemistry Growth Partnership was doing on supply chains. Ian Davey presented the Environment Agency perspective on fracking. Forum member Tom Bowtell told the Forum about the exciting initiative led by the British Coatings Federation to create a circular economy for decorative paint in the UK.

There were updates on the work of the Forum sub-Group on Sustainability, and on international chemicals management. The latter looked in particular at the SAICM’s “Overall Orientation and Guidance for achieving the 2020 goal of sound management of chemicals”.

The Secretariat provided a more detailed outline of the proposed information Sheet on the OECD chemicals work. The Forum also received the usual summary of the latest meeting of the Hazardous Substances Advisory Committee.

The meeting closed with the Forum signing off its draft 2014 Annual Report.

14 July – 61st meeting

The Forum received the usual comprehensive update on various REACH matters from Defra and the UK REACH Competent Authority. Points of discussion included an ongoing European Court case on substances in articles, lead chromates, Member States reports to ECHA on REACH implementation, the registration of low volume substances

Mike Potts and Richard Hawkins combined to give us a double regulators’ perspective on REACH enforcement. The HSE’s “Strategy and Guidance for Enforcement of REACH in the UK” was mentioned specifically.

The Forum spent some time discussing a paper from Defra on the EU Commission’s consultation on the circular economy. The purpose was to form views on how best to integrate chemicals and REACH into the circular economy. The paper included initial views from some Forum members.

We delved deeper into the concerns of SMEs about the 2018 REACH Registration deadline through a survey of EEF members which Susanne Baker presented. This connected well with the work of the Forum’s sub-Group, led by Susanne, on raising awareness of REACH with SMES. The meeting discussed detailed outputs from this sub-Group in the form of draft UKCSF Guidance on REACH Authorisation, and new

UK Chemicals Stakeholder Forum – Annual Report 2015

UKCSF Guidance on the 2018 REACH Registration deadline. Much progress was made towards their intended publication in the autumn.

The Forum also started a discussion on whether it should undertake any work relating to Safety Data Sheets and Extended Safety Data Sheets.

David Taylor presented a paper to report on the progress made by the Forum sub-Group on Sustainability in sourcing relevant information. This had led the sub-Group to seek metrics in three areas initially: Resilience of Supply, Efficiency of Operation and Information Transfer.

Richard Vincent led the Forum through a discussion of various international chemicals management issues, including the level of importance Forum members attached to UK Government participation in international discussions. He reported on the outcomes from the ‘Triple COP’ of the Basel, Rotterdam and Stockholm Conventions which took place in May. He also looked ahead at the 4th International Conference on Chemicals Management in the autumn.

The Forum received a combined BIS-Chemistry Growth Partnership update, as well as a summary of key points from the most recent meeting of the Hazardous Substances Advisory Committee.

Lastly, the Forum welcomed the first Issue of the Defra Information Sheet on the OECD chemicals work.

3 November – 62nd meeting

The REACH updates highlighted the successful conclusion of the work on data-sharing in the form of a Commission Implementing Regulation. This had been a UK priority which would make a significant difference to the costs incurred by SMEs for 2018 Registrations. Members’ attention was drawn to an ECHA press release (2 November) directing registrants to show how they had considered alternative methods before consulting on testing proposals. Other issues covered included the Community rolling action programme, substances in articles, the 5th and 6th ECHA recommendations for additions to the Article XIV list of substances, the consolidation of UK REACH Enforcement Regulations.

Steve Quinn gave a presentation on REACH Authorisation, using his company (West & Senior - an SME involved in colours and additives) as a case study to explore the consequences of having one of his company’s substances listed as a candidate SVHC.

Bridget Ginnity continued ECHA’s engagement with the Forum with a presentation on communication in the supply chain, with a focus on downstream users. She outlined a wide range of ECHA initiatives, including on chemical safety reports and exposure scenarios, as well as the wide range of information available on the ECHA website to support downstream users.

Wayne Smith outlined the work which the European coatings industry was doing on the safe use of mixture information.

UK Chemicals Stakeholder Forum – Annual Report 2015

The Forum also discussed the possibility of undertaking work on Safety Data Sheets, noting that there was already much work in progress in this area led by ECHA which the Forum needed to keep an eye on.

Jon Edwards reported on a number of positive messages which had come from RSC-funded research on public attitudes to chemistry, chemists and chemicals. One of the key findings was that chemists underestimated the positive views of the public about the importance of chemistry in everyday life.

Richard Vincent reported on the outcomes of the recent ICCM meeting and on the Sustainable Development Goals adopted by the UN in September.

The new Forum Guidance on the 2018 REACH Registration deadline, and the updated Forum Guidance on REACH Authorisation, were both signed off for publication and wide dissemination, based on a communications plan drawn up by Susanne Baker, and involving ECHA and the UK REACH Competent Authority.

The work of the Sustainability sub-Group entered a new phase with a specific focus on the World Business Council for Sustainable Development Guidance – Life Cycle Metrics for Chemical Products (a guideline by the chemical sector to assess and report on the environmental footprint of products, based on life cycle assessment). The Secretariat signalled key presentations planned for the next meeting of the Forum from Professor Tom Welton (Imperial College) and from Emily King of ERM to move this work forward. Specific engagement with the WBCSD was also expected.

The Forum received the usual updates from BIS, from Simon Marsh on the Chemistry Growth Partnership, and from Defra on the most recent meeting of the Hazardous Substances Advisory Committee.

The Forum was informed that there would be a wide-ranging and fundamental Review of the UKCSF at the turn of the year.

Chapter 2 -Key activities and outputs

The 2014 Annual Report explained the background to the Forum’s three sub-Groups and the scope of their work.

As reported in a previous annual report, the work of the Forum sub-Group on raising awareness of REACH with SMEs led to the publication of the Forum Guidance on Authorisation. The sub-Group was equally, if not more, productive in 2015. It updated its Guidance on Authorisation, as well as publishing new Guidance on the 2018 REACH Registration deadline.

The Sub-Group on Sustainability embarked on the task of devising relevant metrics. This work received fresh impetus towards the end of the year with the focus on the Guidance from the World Business Council for Sustainable Development on Life Cycle Metrics for Chemical Products. This activity will continue in 2016.

The Sub-Group on international chemicals management has been largely in abeyance in 2015, with attention to this area being addressed direct at Forum meetings, with regular papers from Defra keeping the Forum well-informed on the

UK Chemicals Stakeholder Forum – Annual Report 2015

substance of a range of international meetings and discussions, and with opportunities to contribute to UK positions. The Forum usually has a number of presentations at each of its meetings. These add value to the Forum’s work and provide an opportunity to engage with outside interests and experts. The set of presentations in 2015, set out below, was as interesting and stimulating as in previous years. The Forum Secretariat, with the help of the members, will continue to aim to deliver a rich and varied programme of presentations in 2016.

January

Anna Lennquist (from the Swedish NGO ChemSec, the International Chemical Secretariat), on its Updated SIN List

Nick Boley (laboratory of the Government Chemist) on the Government Chemist advisory function on matters of interest to the UKCSF

April

Harry Swan, Managing Director of Thomas Swan & Co, on the Chemistry Growth Partnership work was doing on supply chains

Ian Davey (Environment Agency) on the EA perspective on fracking

Tom Bowtell (British Coatings Federation) on the BCF’s initiative to create a circular economy for decorative paint in the UK

July

Mike Potts (Health and Safety Executive) and Richard Hawkins (Environment Agency) on REACH enforcement

Susanne Baker (EEF) on a survey of EEF members on the 2018 REACH Registration deadline

November

Steve Quinn (West & Senior) on REACH Authorisation – a case study

Bridget Ginnity (ECHA) on communication in the supply

Wayne Smith (BCF) on downstream users’ approach to mixture exposure scenarios

Jon Edwards (RSC) on public attitudes to chemistry, chemicals and chemists

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex A: UK Chemicals Stakeholder Forum – Terms Of Reference

The purpose of the Forum is to advise Government on managing risks to the environment and to human health via the environment that may result from the production, distribution and use of chemicals. Recognising the changing circumstances in which chemicals are regulated, the Forum aims to be a strategic body, paying due regard to the promotion of sustainable consumption and production throughout the chemicals supply chain, to the life cycle of chemicals, to the precautionary principle, and to the need to add value and not replicate activities undertaken elsewhere.

In particular it will:-

review the effectiveness of REACH in realising its goals in the light of the experience and needs of UK stakeholders;

review the effectiveness of the UK Competent Authority in delivering its obligations under REACH, and engage it in an on-going dialogue to reflect stakeholder views and concerns;

advise Government on measures to promote the sound management of chemicals internationally;

continue to promote voluntary action by industry in the UK where this can make a contribution to a reduction in the overall use of those substances recognised by the Forum as being priorities for action;

communicate and encourage best practice and innovation, and encourage others to do so;

promote more effective linkages throughout the chemicals supply chain, and between all those with an interest in the future of a sustainable and competitive UK chemicals industry.

In order to measure the effectiveness of the activities above as they relate both to itself and others, the Forum will develop key performance indicators against which it can assess performance.

(2008)

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex B: Forum members and attendance at meetings in

2015

Forum members in 2015

The organisations represented on the UK Chemicals Stakeholder Forum in 2015 were as listed below.

ADS (UK Aerospace, Defence, Security and Space Industries) British Association for Chemical Specialities

British Coatings Federation British Plastics Federation British Retail Consortium Business Council for Sustainable Development – United Kingdom Chemical Business Association Chemical Industries Association Chemicals, Health and Environment Monitoring (CHEM) Trust Cruelty Free International1 EEF, the manufacturers’ organisation Environmental Services Association Federation of Small Businesses Green Chemistry Network

Greenpeace National Federation of Women’s Institutes Non-Ferrous Alliance

Royal Society of Chemistry Society of Chemical Industry TechUK Trades Union Congress

UK Cleaning Products Industry Association Wales Environment Link The Forum also has one individual expert, Dr Mike Holland, who is not associated with a particular organisation. He is an expert on socio-economic aspects under REACH.

For a current list of Forum members and their named representatives see the UKCSF website - https://www.gov.uk/government/groups/uk-chemicals-stakeholder-forum#membership

1 Formerly known as the British Union for the Abolition of Vivisection – name change occurred between April

and July meetings

UK Chemicals Stakeholder Forum – Annual Report 2015

Attendance at meetings in 2015

Summary of members’ attendance

27/1 28/4 14/7 3/11

ADS/Wyn Griffiths, Kevin Morris*, Cathy Phillips Y Y Y Y

BACS/John Reid Y Y Y Y

BCF/Tom Bowtell, Wayne Smith* Y Y Y Y

BPF/Philip Law, Matthew Davies* Y Y Y Y

BRC/ Linda Crane, Spencer Salek*, David Bolton Y Y Y Y

BCSD-UK Pat Laughlin, Victoria Lambert* N Y Y Y

CBA/Michael Cooper Y Y Y Y

CIA/Joanne Lloyd, Claudine Albersammer*, Nishma Patel Y Y Y Y

CHEM Trust/Gwynne Lyons, Michael Warhurst* Y Y Y Y

KTN/Steve Fletcher N Y Y N

Cruelty Free International/Katy Taylor Y Y Y N

EEF/Susanne Baker, Claire Jakobsson Y Y Y N

ESA/Ray Parmenter Y Y Y Y

FSB/Andrew Poole Y Y N N

GCN/James Clark, Dick Powell* Y Y Y Y

Greenpeace/David Santillo Y Y Y Y

NFWI/Glenis Wedzicha Y Y Y N

NFA/Piat Piatkiewicz N Y Y Y

RSC/David Taylor, Paul Whitehead* Y Y Y N

SCI/Martin Elliott Y Y Y Y

TechUK/Julian Lageard, Susanne Baker Y Y Y Y

TUC/Bud Hudspith Y Y Y N

UKCPI/Philip Malpass Y Y Y Y

Mike Holland N Y N Y

UK Chemicals Stakeholder Forum – Annual Report 2015

All attendance by meeting in 2015

59th Meeting – 27 January David Phillips Chairman Patrice Mongelard Secretariat Forum members Susanne Baker EEF Tom Bowtell British Coatings Federation James Clark Green Chemistry Network Michael Cooper Chemical Business Association Linda Crane British Retail Consortium Matthew Davies** British Plastics Federation Martin Elliott Society of Chemical Industry Wyn Griffiths ADS Bud Hudspith Trades Union Congress Julian Lageard TechUK Joanne Lloyd Chemical Industries Association Gwynne Lyons Chemicals, Health and Environment Monitoring (CHEM) Trust Philip Malpass UK Cleaning Products Industry Association Ray Parmenter Environmental Services Association Andrew Poole Federation of Small Businesses John Reid British Association for Chemical Specialities David Santillo Greenpeace Katy Taylor British Union for the Abolition of Vivisection David Taylor Royal Society of Chemistry Glenis Wedzicha National Federation of Women’s Institutes Defra Keith Bailey REACH Team Arwyn Davies Head of Chemicals and Emerging Technologies Duncan Egerton REACH Team Steve Morris International Chemicals Emma Stuart HSAC Secretary Richard Vincent International Chemicals Devolved administrations/Other Government Departments Douglas Bush Department for Business Innovation and Skills Stavros Georgiou HSE Chemicals Regulation Directorate* Martin McVay Welsh Government Sravya Rao Department for Business Innovation and Skills Deborah Trainer HSE International Chemicals Unit Others Claudine Albersammer Chemical Industries Association Rebecca Barnett EUK Consulting Tony Bingham AGB Chemical Compliance Nick Boley Laboratory of the Government Chemist

UK Chemicals Stakeholder Forum – Annual Report 2015

Matteo Dalla Valle Chevron Oronite Ciara Dempsey Royal Society of Chemistry Anna Lennquist CHEMSEC Steven Lipworth Royal Society of Chemistry Simon Marsh Chemical Industries Association Sean McPike Eli Lilly and Company John Parkes WIL Research Rachel Salvidge ENDS Report Lucy Stafford EUK Consulting Bill Watts Independent consultant 60th Meeting – 28 April David Phillips Chairman Patrice Mongelard Secretariat Forum members Susanne Baker EEF Tom Bowtell British Coatings Federation James Clark Green Chemistry Network Michael Cooper Chemical Business Association Matthew Davies** British Plastics Federation Martin Elliott Society of Chemical Industry Steve Fletcher Knowledge Transfer Network Mike Holland Independent expert on socio-economic assessment Bud Hudspith Trades Union Congress Julian Lageard TechUK Victoria Lambert** UK Business Council for Sustainable Development Joanne Lloyd Chemical Industries Association Gwynne Lyons Chemicals, Health and Environment Monitoring (CHEM) Trust Philip Malpass UK Cleaning Products Industry Association Kevin Morris** ADS Ray Parmenter Environmental Services Association Piat Piatkiewicz Non-Ferrous Alliance Andrew Poole Federation of Small Businesses John Reid British Association for Chemical Specialities Spencer Salek** British Retail Consortium David Santillo Greenpeace Katy Taylor British Union for the Abolition of Vivisection Glenis Wedzicha National Federation of Women’s Institutes Paul Whitehead** Royal Society of Chemistry Defra Keith Bailey REACH Team Duncan Egerton REACH Team Simon Johnson Resource Efficiency Steve Morris International Chemicals Ian Sutherland International Chemicals Richard Vincent International Chemicals

UK Chemicals Stakeholder Forum – Annual Report 2015

Devolved administrations/Other Government Departments Alastair East Department for Business Innovation and Skills Ian Davey Environment Agency Stavros Georgiou HSE Chemicals Regulation Directorate* Sravya Rao Department for Business Innovation and Skills Chong-Phi Vong Department for Business Innovation and Skills Others Claudine Albersammer Chemical Industries Association Tony Bingham AGB Chemical Compliance Nick Boley Laboratory of the Government Chemist Ciara Dempsey Royal Society of Chemistry Steven Lipworth Royal Society of Chemistry Simon Marsh Chemical Industries Association Sean McPike Eli Lilly and Company John Parkes WIL Research Mamta Patel Chemical Watch Silvia Segna Chemical Industries Association Harry Swan MD Thomas Swan & Co Ltd Susie Wilks Humane Society International 61st Meeting – 14 July David Phillips Chairman Patrice Mongelard Secretariat Forum members Claudine Albersammer** Chemical Industries Association Susanne Baker EEF David Bolton British Retail Consortium Michael Cooper Chemical Business Association Matthew Davies** British Plastics Federation Martin Elliott Society of Chemical Industry Steve Fletcher Knowledge Transfer Network Wyn Griffiths ADS Bud Hudspith Trades Union Congress Julian Lageard TechUK Victoria Lambert** UK Business Council for Sustainable Development Philip Malpass UK Cleaning Products Industry Association Ray Parmenter Environmental Services Association Piat Piatkiewicz Non-Ferrous Alliance Dick Powell** Green Chemistry Network John Reid British Association for Chemical Specialities David Santillo Greenpeace Wayne Smith** British Coatings Federation David Taylor Royal Society of Chemistry Katy Taylor Cruelty Free International Michael Warhurst** Chemicals, Health and Environment Monitoring (CHEM) Trust Glenis Wedzicha National Federation of Women’s Institutes

UK Chemicals Stakeholder Forum – Annual Report 2015

Defra Keith Bailey REACH Team Arwyn Davies Head of Chemicals, Pesticides and Industrial Emissions Duncan Egerton REACH Team Neil Fourie Resource Efficiency Chetal Owens Resource Strategy Yasmina Salas Resource, Atmosphere and Sustainability Emma Stuart HSAC Secretary Ian Sutherland Chemicals Richard Vincent International Chemicals Devolved administrations/Other Government Departments Douglas Bush Department for Business Innovation and Skills Alastair East Department for Business Innovation and Skills Stavros Georgiou HSE Chemicals Regulation Directorate* Richard Hawkins Environment Agency Mike Potts HSE Chemicals Regulation Directorate* Others Tony Bingham AGB Chemical Compliance Nick Boley Laboratory of the Government Chemist Linda-Jean Cockcroft RPA Ellen Daniels British Coatings Federation Ciara Dempsey Royal Society of Chemistry Dale Iddon Eli Lilly and Company Steven Lipworth Royal Society of Chemistry Sean McPike Eli Lilly and Company John Parkes WIL Research Geraint Roberts Chemical Watch Rachel Salvidge ENDS Report Silvia Segna Chemical Industries Association Melissa Wang Greenpeace Bill Watts Independent Consultant 62nd Meeting – 3 November David Phillips Chairman Patrice Mongelard Secretariat Forum members Susanne Baker TechUK David Bolton British Retail Consortium Tom Bowtell British Coatings Federation James Clark Green Chemistry Network Michael Cooper Chemical Business Association Matthew Davies** British Plastics Federation Martin Elliott Society of Chemical Industry Mike Holland Independent expert on socio-economic assessment Pat Laughlin UK Business Council for Sustainable Development Philip Malpass UK Cleaning Products Industry Association

UK Chemicals Stakeholder Forum – Annual Report 2015

Ray Parmenter Environmental Services Association Nishma Patel Chemical Industries Association Cathy Phillips ADS Piat Piatkiewicz Non-Ferrous Alliance John Reid British Association for Chemical Specialities David Santillo Greenpeace Michael Warhurst** Chemicals, Health and Environment Monitoring (CHEM) Trust Defra Keith Bailey REACH Team Morwenna Carrington Head of Chemicals, Pesticides and Industrial Emissions Duncan Egerton REACH Team Ian Sutherland Chemicals Richard Vincent International Chemicals Devolved administrations/Other Government Departments Douglas Bush Department for Business Innovation and Skills Alastair East Department for Business Innovation and Skills Andrew Smith HSE Chemicals Regulation Directorate* Others Tony Bingham AGB Chemical Compliance Steve Binks International Lead Association Nick Boley Laboratory of the Government Chemist David Brown West & Senior Linda-Jean Cockcroft RPA Tess Crean Client Earth Mindy Dulai Royal Society of Chemistry Jon Edwards Royal Society of Chemistry Bridget Ginnity ECHA Steven Lipworth Royal Society of Chemistry Jo Lloyd ERM Simon Marsh Chemical Industries Association Sean McPike Eli Lilly and Company John Parkes WIL Research Mamta Patel Chemical Watch Steve Quinn West & Senior Elisabeth Ratcliffe Royal Society of Chemistry Joanna Sacks Consortium of Local Education Authorities for the Provision of Science

Services Silvia Segna Chemical Industries Association Stephen Senior West & Senior Wayne Smith British Coatings Federation Hannu Vornamo Helsinki Chemicals Forum * HSE Chemicals Regulation Directorate/UK REACH Competent Authority ** deputy in attendance

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex C: A guidance note from the UK Chemicals Stakeholder Forum - What you need to know about REACH Authorisation Version 2, November 2015

Introduction

REACH, which stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, is a substantial piece of legislation controlling chemicals within the EU. It aims to improve the protection of human health and the environment from the risks of chemicals and stimulate innovation in the chemicals industry.

Authorisation is one of the REACH processes for managing the risks of certain hazardous substances, known as “Substances of Very High Concern” (SVHC), and promoting their replacement with safer alternatives. Substances that are subject to authorisation may not be used in the EU past their pre-determined “sunset” dates unless a company has been authorised to do so. This means use of the substance will only be permitted if there is adequate control or if there are clear benefits in continuing to use it.

This leaflet provides you with an introduction to REACH authorisation and what it might mean for your business. It also tells you where you can go to find out further information and get help. It has been prepared by the UK Chemicals Stakeholder Forum to help smaller companies in particular understand what the likely impacts of authorisation will be. The European Chemicals Agency (ECHA) is the body responsible for the administration of this legislation. You can find information on the REACH legal text, on-going consultations and current applications for authorisation on its website.

Will authorisation affect my business?

REACH applies to chemical substances on their own, in mixtures and in articles (objects). As such, REACH has the potential to impact all UK business sectors. From chemical manufacturers, furniture makers and retailers to builders, food manufacturers and printers – all businesses use chemicals in their day-to-day operations.

Your business will be affected if you currently rely on a substance that is going to become subject to authorisation. The effect can be either direct, if you use the substance, or indirect if your business purchases products or materials which are made using that substance.

You will no longer be able to use the substance in the EU once its “sunset date” has passed, regardless of how important it is to your business, unless your specific use has been authorised. Conversely, there could be market opportunities for your business if it provides alternatives that could be used to replace substances that are being considered for authorisation.

That said, business should not unduly fear authorisation. Many businesses have chosen not to apply for authorisation, readily finding alternatives to the substance in question. Moreover, the application process for authorisation appears to be working and a number of successful applications have now been processed.

What are my options if a substance I use, directly or indirectly, will be subject to authorisation? You have five key options:

• Replace the substance with a suitable alternative or adapt your process to avoid its use. • Switch to products (articles) that avoid the use of the substance. • Consider applying for authorisation. • Ensure your use is covered by another authorisation. • Cease use in the EU.

UK Chemicals Stakeholder Forum – Annual Report 2015

Where can I find out more about substitution?

Substitution is the replacement of a substance, process, product or service by another that maintains the same functionality. If a substance critical to your business is subject to authorisation then substitution may offer a solution. However, this needs to be done with care. The viability of substitutes needs to be assessed on health and environmental grounds as well as their technical performance and economic feasibility.

The UK Chemicals Stakeholder Forum has produced a useful introductory guide to substitution which describes the process and its potential pitfalls. Help and guidance is also available online and

Subsport is a good starting point. This is a free information exchange on alternative substances and technologies, as well as providing tools and guidance for substance evaluation and substitution

management.

In some cases, even though there may be substitution options available to you, you may still need to apply for authorisation to ensure there is adequate time to implement changes or to secure sufficient quantities of the alternative to meet your needs.

How can I obtain permission to continue to use a substance that will be subject to Authorisation?

Companies need to apply to the European Chemicals Agency (ECHA) for authorisation. Permission to

continue to use a substance on the Authorisation List can be granted if the applicant demonstrates

that:

• The risks from the use of the substance are adequately controlled (i.e. exposure does not exceed levels which may cause adverse effects to human health and the environment). This route only applies for substances for which a safe level (“derived or predicted no effect level”) can be determined; or

• The risks to human health or the environment from the use of the substance are outweighed by the benefits to society and there are no suitable alternative substances or technologies available. This route is for use for SVHCs for which a safe level (“derived or predicted no effect level”) cannot be determined or when adequate control cannot be demonstrated.

Applications for authorisation need to include:

• A chemical safety report covering the risks arising from the substance’s properties and

demonstrating how those risks should be managed.

• An analysis of alternatives considering alternative substances, the technical and economic feasibility of using a different substance and any research and development activities you are doing to search for an alternative.

• A substitution plan outlining research, action and timeline required to switch to alternative

substances and technologies if they exist but aren’t immediately available.

• A socio-economic analysis, if required or recommended. This should clearly demonstrate

that the benefits to society of using the substance outweigh the costs to human health and

the environment.

Whilst some information can be taken from generic sources, the application will need to provide a

significant amount of data specific to your company. ECHA has systems in place to safeguard

information that is commercially sensitive.

You will have one opportunity to discuss your draft application with ECHA ahead of submitting your

application, in a Pre-Submission Information Session. Once submitted, applications are considered

by two committees of independent scientific experts at ECHA, and subject to public consultation,

before forming an opinion as to whether or not, in their view, the conditions for authorisation have

UK Chemicals Stakeholder Forum – Annual Report 2015

been fulfilled. These opinions are then considered by the European Commission which takes the final

decision on granting authorisation.

Seeking authorisation can be time consuming and resource intensive. It is therefore important that

you are proactive in managing the application and that the project is thoroughly planned. Before

deciding to apply you must consider all the options available to you. It is essential for you to fully

understand what the impact would be if you can no longer use the substance in the EU.

The European Commission is currently considering a number of options to simplify applications in a

limited number of cases (substances used in spare parts and repairs and those used in low volumes).

How are substances added to the Authorisation List? There are three key steps before a substance is subject to authorisation. The process is outlined in

Diagram 1 and explained below.

Diagram 1: How substances are chosen for authorisation

Identifying the most appropriate risk management measure (Step1)

Through screening activities, authorities identify potential substances of concern that might require

further action. ECHA or a Member State carries out a risk management options (RMO) analysis to

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decide whether measures are needed and, if so, what the most appropriate action would be.

Substances being examined are listed in the Public Authority Coordination Tool, on ECHA’s website.

If it is agreed that Authorisation is the most appropriate route, it is notified in ECHA’s registry of

intentions (RoI). This gives advance warning of ECHA’s or Member States’ intentions.

Inclusion of SVHCs on the candidate list (Step 2)

Once on the RoI, the Member State or ECHA prepares a justification dossier (also known as an

‘Annex XV dossier’) to set out why the substance can be defined as an SVHC and should be included

on the Candidate list for authorisation. The dossier is subject to a public consultation, during which

interested parties can submit relevant information.

Prioritisation and inclusion in the authorisation list (Step 3)

Periodically, ECHA is required to recommend to the Commission which substances from the

Candidate List should be prioritised for authorisation, based on the substance’s properties, uses and

volumes. ECHA’s draft recommendation is subject to a public consultation. The Commission, in

collaboration with Member States, finally decides whether the proposed substances should be

included in the Authorisation List (REACH Annex XIV).

It is important to note that while not all substances on the Candidate List will be recommended for authorisation, substances are being prioritised for authorisation every year and once that occurs the inclusion in the Authorisation List is a relatively quick process.

What are the key dates to consider in the authorisation process? The Authorisation List outlines the date by which the use of the substance must stop (“the sunset

date”) without authorisation, and any exemptions. Sunset dates are typically (but not always) set

three years after the substance has been added to Annex XIV.

If you cannot substitute the substance and are considering continuing to use it, an application for authorisation must be submitted. The Authorisation List includes the “latest application date”, which is set at least 18 months before the sunset date. Companies meeting this deadline can continue to use the substance after the sunset date until their authorisation application has been fully processed.

How can I keep track of which substances are being targeted? It is important to monitor developments in order to plan for, and manage, potential changes. You

should monitor the Public Authority Coordination Tool, the Registry of Intentions, the Candidate List

and the Authorisation List. These are regularly updated. The Candidate List is usually updated twice a

year and public consultations occur in March-April and September-October ahead of the update.

Details of substances that are being prioritised for inclusion on Annex XIV can be found on the ECHA

website. Consultations on new proposals typically run in the autumn each year.

You can also sign up for ECHA news alerts or the HSE eBulletin. Organisations such EEF and REACHReady also provide free alerts. These services will notify you when substances are identified as SVHCs, subject to consultation and prioritised for inclusion in, or added to, Annex XIV.

Are there any exemptions to authorisation?

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Yes. Some uses of substances are automatically exempt from the requirements of authorisation. This

means that they can still be used in certain circumstances even if they have been included on the

Authorisation list. This is mostly because risks posed by the substance are already controlled through

other existing European legislation. The exemptions are detailed in Article 2 and Article 56 of REACH

and include, for example, substances used in medicinal or veterinary products, substances used in

food and feed stuffs and on-site isolated and transport isolated intermediates. Check before starting

any work and always seek clarification from your competent authority (the HSE in the UK).

Is it possible to challenge proposals for substances to be subject to authorisation?

There are a number of opportunities for interested parties to input into the authorisation process,

and this can affect whether or not a substance ends up on Annex XIV.

It is important that you monitor consultations and input when you can. The most effective way is to submit comments via industry sector groups and trade associations. Information on uses of the substance (including information on the tonnages used per use, exposures or releases resulting from these uses, the complexity of the supply chain, views on transitional arrangements, proposals for exemptions, etc.) is particularly welcomed.

It may also be prudent to engage with Member States or ECHA when they are preparing a dossier

identifying a substance as a SVHC. This could prevent the substance being listed on the candidate

list, for example if it can be demonstrated that there are other more effective ways to manage the

risks posed by the substance (e.g. restriction) than authorisation.

Does authorisation apply to research and development activities? Maybe. If you use a substance for scientific research and development, then this is exempt. Scientific research and development is defined as any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume of less than 1 tonne per year. This would include using a substance for monitoring or control purposes.

There is also discretion to exempt, on a case-by-case basis, the use of a substance for product or

process orientated research and development (PPORD). If you want to use a substance subject to

authorisation for PPORD you will need to check Annex XIV to see whether an exemption is in place.

Does authorisation apply to imported goods? Yes and no. Authorisation only applies to chemical substances. An importer cannot import a

substance on Annex XIV (on its own or in a mixture) after the sunset date unless an authorisation has

been granted which allows them to do so. However, authorisation applies only to the use of the

substance in the manufacture of an article, not to the presence of the substance in the article itself.

Therefore, articles containing a substance on Annex XIV can be imported into the EU without the

need for an authorisation. However, in order to produce the article within the EU using a substance

on Annex XIV, an authorisation would be required. Both EU producers and importers of articles have

an obligation under certain conditions to notify ECHA about the presence of “candidate list

substances” in the articles. More information on the notification of substances in articles can be

found on the ECHA website.

It is also important to note that a substance within an article could be proposed for a ‘restriction’ if it is deemed to present risks to human health and/or the environment which are not being sufficiently controlled. Substances which are subject to a restriction are listed in Annex XVII of REACH. If a

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restriction is introduced for a substance, its presence in an article (either produced in the EU or

imported from outside the EU) could be limited or prohibited altogether.

Who can apply for authorisation? European chemical manufacturers, chemical importers, Only Representatives of non-European

chemical manufacturers, formulators and companies using chemicals downstream (and any

combination of these) can apply for an authorisation. Companies that use chemicals have a

fundamental role as applications are required for the “use” of the substance. These “downstream

users” have two options if they wish to use a substance subject to authorisation:

• Obtain the substance from a manufacturer, importer or another downstream user that holds a valid authorisation for that particular use.

• Directly apply for authorisation for their use.

A chemical manufacturer or importer may submit an application to cover all users down the supply

chain. Under these circumstances, downstream users must notify ECHA if they are using a substance

for which an authorisation has been granted for their use. If an authorisation is granted directly to a

downstream user, it only allows for the substance to be “placed on the market” for that use by its

immediate supplier (one level up that supply chain).

Early communication in the supply chain is therefore crucial. Chemical manufacturers and downstream users should share information and discuss the most efficient way to cooperate. The dominant company in the supply chain may have an interest in coordinating action.

How long do authorisations last? Authorisations do not last forever. When an authorisation is granted, a ‘time-limited review period’ is set. The duration of the review period is assigned on a case-by-case basis, taking into account information in the application. The likely (default) review periods are 4, 7 or 12 years. Towards the end of the review period, if the company wants to continue using the substance, it must submit an updated application for authorisation, which will be assessed as before.

In practice, you are more likely to have a short review period if there are uncertainties in your application. Clearly outline in your application what review period you are seeking and why.

Is the Authorisation process different for SMEs? No, REACH provisions apply to all EU companies, and importers, irrespective of company size.

How much does an application cost?

A fee must be paid to ECHA for each authorisation application. The level of the fee depends on the

number of uses, substances and applicants covered by the application. There are reduced fees for

companies qualifying as medium, small and micro-enterprises as per the EU SME definition. The

reduced base fee covering one applicant, one substance and one use ranges from €40,575 for a

medium-sized business to €5,410 for a micro-sized business. Please note that ECHA verifies the SME

status of all applicants and administrative charges apply in case of incorrect claims. ECHA have a

“Fee Calculator Tool” available to estimate the fee for authorisation applications.

However, note that the application fee is likely to represent only a small fraction of your costs. You will incur additional costs if consultancy support is needed, if you need to access technical information or if the preparation work is carried out with others or if legal disputes arise between

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parties. These costs can be significant. Experience from applications so far suggest an average total cost of €230,000. You should be confident of success before deciding whether applying for authorisation is the best course of action.

What steps can I take to reduce authorisation application costs?

You should first familiarise yourself with the process to understand what you can do in-house and

what needs to be done externally. When using consultants it is strongly advised that you shop

around for best value, possibly allocating different parts of the application to different consultants,

as experience dictates.

It is possible to cooperate with other applicants during the preparation of some, or all, of the application. There are benefits and disadvantages in doing so. In some cases, it might help to reduce costs, though in others the added complexity of ensuring that confidential information remains confidential may add layers of management that increase costs.

Deciding when to work together and which aspects of the application to submit individually will be an important decision. Parts may need to be completed individually to maintain business confidentiality, for example the analysis of alternatives or the socio-economic analysis, or if you are describing processes that demonstrate controlled use of the chemical. However it may benefit the application to conduct a joint analysis of the wider impact of a product’s use. If you do decide to work with other applicants, be mindful of competition law.

What should I be asking my supplier?

If you use a substance subject to authorisation, you may want to ask your suppliers what their

intentions are. For example, whether they are considering substitutions or whether they intend to

apply for authorisation. In the latter case, you should ensure they receive information to cover your

use and those of your customers. If the authorisation is granted, your supplier will provide you with

an authorisation number on the product’s label and safety data sheet. If you decide to obtain an

authorisation for your own use, you should ensure that your supplier intends to continue to supply

the substance in the long term.

Once an authorisation has been granted, do other provisions of REACH still apply?

Yes. Other provisions of REACH continue to apply to the substance, as may be relevant.

How can I find out more?

You may be able to find out more about authorisation and whether it will affect your business from

your supplier or others within your supply chain. You should also contact sector organisations, which

may be coordinating or signposting relevant activity or may have developed guidance specifically for

your area of business. The UK Competent Authority provides a REACH helpdesk. The helpdesk

service is free and confidential and can be contacted at UKREACHCA@hse.gsi.gov.uk.

There are also a number of guidance materials available that you may find helpful:

• Industry guidance: REACH authorisation guidance for downstream users:

• HSE bite-size information leaflets

ECHA website and ECHA Factsheet on applications for authorisation

• ECHA’s Guidance on the preparation of an application for authorisation and Guidance on

Socio-Economic Analysis – Authorisation

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This guidance was drafted by a sub-Group of the UK Chemicals Stakeholder Forum comprising: Susanne Baker (EEF, the Manufacturers’ Organisation) (Chair), Jo Lloyd (formerly Chemical Industries Association), David Santillo (Greenpeace), Silvia Segna (Chemical Industries Association) and David Taylor (Royal Society of Chemistry). Non-Forum members - Keith Bailey (Defra), Patrice Mongelard (Defra), Lindsay Peppin (HSE), Stavros Georgiou (HSE), Mike Holland (EMRC) and Richard Dubourg (The Economics Interface Limited) - also contributed to this work. While we have made every effort to ensure that the information provided in this document is accurate and up to date, no legal responsibility is accepted for any errors, omissions or misleading statements. We accept no responsibility or liability whatsoever with regard to the information in this document. In principle, this information is not professional or legal advice. If you need specific advice, you should always consult a suitably qualified professional.

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex D: A guidance note from the UK Chemical

Stakeholder Forum - What SMEs need to know about the 2018 REACH Registration deadline

Version 1, November 2015 Introduction REACH is a substantial piece of legislation controlling the manufacture, import and use of chemicals within the European Union/European Economic Area (EU/EEA). The acronym stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. Its main purpose is to ensure that industry is responsible for the safe use of chemicals throughout the supply chain, contributing to a high level of protection of human health and the environment, and to facilitate the free circulation of chemical substances within the internal market (“substances” is the term used in REACH and in this advice note). The European Chemicals Agency (ECHA) is the body responsible for the administration of this legislation.

REACH applies to substances on their own, in mixtures and in articles (objects). As such, it has the potential to impact all UK business sectors from chemical manufacturers, furniture makers and retailers to builders, food companies and printers. Most businesses use chemicals, in some form, in their day-to-day operations.

This advice note provides a brief introduction to the registration element of REACH. The UK Chemicals Stakeholder Forum has prepared this paper as we approach a key milestone - 31 May 2018 - the registration deadline for tens of thousands of substances, which are manufactured or imported in quantities between 1 and 100 tonnes per year (substances used in high tonnages have already been registered). “Import” means import into the EU/EEA.

Each individual company manufacturing or importing substances has to register them, jointly with other companies manufacturing or importing the same substance. We are concerned that many companies, in particular smaller ones, are not aware of, or are not actively preparing for, registration. Registration will affect namely any companies and supply chains that use substances and hence depend on them. In the worst case, if nobody registers a substance, it will no longer be available on the market. That’s a business continuity risk that all companies should want to avoid.

1. What is registration? Registration is a legal requirement under REACH. Each EU/EEA company that manufactures or imports 1 tonne or more of a substance a year must collect a standard set of data on that substance. The data is used to assess its hazards and ensure that any risks to human health and the environment are controlled. A registration dossier must be submitted to ECHA for this purpose.

Most substances already manufactured or placed on the market before REACH came into force – known as “phase-in” substances – can benefit from staggered registration deadlines, based on volume and hazard properties. A company must have pre-registered the substance by 1 December 2008 to benefit from these extended deadlines.

Each EU/EEA company manufacturing or importing phase-in substances in medium or high volumes (above 100 tonnes a year) should have registered them by now, in the two previous rounds of registrations in 2010 and 2013. By 31 May 2018, phase-in substances manufactured or imported in volumes between 1 tonne and 100 tonnes a year must also be registered.

2. How do I know if I need to register a substance?

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Pre-registration

- Took place between 1 June and 1 Dec 2008;

-Allowed companies to inform ECHA about which phase-in substances they intended to register and benefit from an extended registration deadline;

- It is company specific: as general rule, it cannot be transferred/sold to another company;

-Check in REACH IT whether your company pre-registered, particularly if there have been personnel changes since 2008;

-“Late pre-registration” does not apply to companies that failed to pre-register by 1 December 2008;

“Late pre-registration” is free and relatively simple. Step by step instructions on how to prepare an online pre-registration is explained by ECHA here

;

If your company manufactures or imports any pre-registered phase-in substances in quantities between 1 tonne and 100 tonnes a year and you have not yet registered them under REACH, the registration deadline of 31 May 2018 is likely to apply to you. You should review your portfolio and identify those substances that are subject to registration, refresh your knowledge of REACH and consider your course of action. Figure 1 gives you a general indication on how to determine if you have registration obligations. REACH defines phase-in substances as those that:

Are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS), or

Were manufactured in EU countries in the past but have not been placed on the EU market since 1 June 1992; or

Substances that qualify as "no-longer polymer'' (see NLP entry here)

If your substance is “new” (i.e. ‘non-phase-in’) or is a phase-in substance that has not been pre-registered, you must submit an inquiry to ECHA and register it before you can manufacture or import the substance at 1 tonne or more per year.

The EC Inventory database can be used to assess whether your substance is “phase-in” or “non phase-in”. More information on how to make sure that you properly identify the substances for registration purposes is available on the ECHA guidance for identification and naming substances.

If your substance meets one of the phase-in criteria above but has not been pre-registered, you could still benefit from the delayed 31 May 2018 registration deadline, if you are eligible for “late pre-registration”. Late pre-registration is open only to those companies who manufacture or import a phase-in substance in quantities between 1 tonne and 100 tonnes per year for the first time after 1 December 2008. You must submit a late pre-registration within six months after manufacturing or import exceeds 1 tonne and no later than 31 May 2017. Carcinogens, mutagens or reproductive toxicants (CMR substances) are not eligible for late registration.

3. Are there any exemptions to registration? There are a few substances for which exemptions exist. Exemptions include radioactive substances, substances in transit and those in customs warehouses intended for re-export outside the EU/EEA, and waste (as defined by other EU legislation). There are no registration obligations for substances that already require some other kind of registration or licence before they can be used in Europe, e.g. human and veterinary medicines, food additives, and the active substances used in plant protection products and biocidal products.

REACH Annexes IV and V list individual substances or categories of substances which are exempt from registration. The substances in Annex IV are typically of natural origin and are exempted because they are considered to be of minimal risk. For the categories in Annex V (e.g. naturally occurring minerals and ores) registration is deemed inappropriate or unnecessary.

There are also registration exemptions in place for some recovered materials, such as compost. For some other substances, including chemical intermediates (a substance that is manufactured for, and

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consumed or used in, chemical processing in order to be transformed into another substance), there are reduced information requirements as long as particular conditions are met.

The UK HSE has provided a useful leaflet on exemptions to REACH registration. More detailed information on Annex V exemptions from ECHA is available here.

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Fig.1. How to determine whether you have registration obligations - general overview

(Please consult the ECHA 2018 webpages and registration guidance to clarify registration obligations for your specific substance)

UK Chemicals Stakeholder Forum – Annual Report 2015

4. What do I have to do if I have registration obligations? Once you know that your substance has to be registered, you should find out if the substance has already been registered by others or, if not, which other companies intend to register it. You then need to engage with them to prepare the joint part of the registration, submit your individual part of the registration dossier and pay your registration fee to ECHA. Once you have successfully registered, REACH requires you to keep the information in your dossier updated as necessary. Figure 2 represents a step-by-step overview of the registration process. Please bear in mind that:

You need to estimate the average tonnage per year of the phase-in substance that you will manufacture or import for the three years before you register. This is important because the amount of information you have to include with your registration will differ depending on whether the answer is 1-10 tonnes or 10-100 tonnes. Consult the ECHA guidance on registration for more information on how the tonnage is calculated.

To minimise cost and avoid unnecessary animal testing, registration is based on the principle of “one substance, one registration”. Registrants must work together in Substance Information Exchange Forums (SIEFs). SIEF members gather the information they need to register the substance, share data on its intrinsic properties and agree on its classification and labelling. Some of the data should already be available, but where there are data gaps testing may be required. Registrants have the obligation to share all test data on vertebrate animals.

It is important to check that the substance you intend to register really is the same as the one covered by the SIEF. You need to justify “sameness” of the substance based on your own data and the substance identity description provided by the SIEF. If the substance has not already been registered in one of the earlier deadlines, one of the first tasks of companies will be to agree on substance identity covered by the joint registration.

For each substance, one company takes the role of lead registrant. The lead registrant's tasks are to submit the joint part of the registration dossier, establish the platform for joint registration (“joint submission object”) in REACH-IT and distribute the security token so that all co-registrant can join the platform and submit their individual parts of the registration dossier. All co-registrants are responsible for making sure that the registration is done on time according to the legal requirements. In practice, the lead registrant often takes the task to produce the joint part of the dossier. This is a complete dossier containing all the required data for physicochemical, toxicological and environmental properties. The co-registrants then refer to the lead dossier, in particular for the technical data about the substance.

After the lead registrants has submitted the joint part of the registration, the other co-registrants then submit “member dossiers” containing information specific to their company, substance identification, information on how their substance is used, and their production or import volumes.

If the quantity manufactured or imported is 10 tonnes a year or more, you need to carry out a Chemical Safety Assessment (CSA) to assess the intrinsic properties, manufacture, use, exposure and risk of the substance. If the substance fulfils certain hazard criteria, the CSA must include an assessment of the exposure to demonstrate that the risk can be controlled with a set of operational conditions and risk management measures. The CSA is documented in a Chemical Safety Report (CSR) by the registrant. The CSR can be submitted by companies separately, or as part of the joint part of the registration dossier covering all identified uses of the substance.

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There is a dedicated software package called IUCLID for producing registration dossiers. ECHA’s “Submission Manual 5” helps identify which sections of IUCLID should be filled in for a lead registrant dossier, or for a co-registrant dossier. The manual is regularly updated. The dossiers must then be submitted to ECHA through the ECHA REACH-IT portal. Each company must create an online account in REACH-IT. New versions of IUCLID and REACH IT will be made available in 2016, so you might consider waiting for the new tools to produce and submit your dossier.

Fig.2. Step-by-Step overview of the registration process

(Please consult the ECHA 2018 webpages and ECHA guidance for more information)

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5. What is a SIEF and what is a consortium? A SIEF is the formal group of companies who have pre-registered the same substance. One SIEF covers one substance. Being part of the SIEF is a legal obligation for all registrants of the same pre-registered substance.

A consortium is a voluntary organisation of companies who have decided to work together. A consortium can cover more than one substance and its remit may go beyond preparing REACH registration dossiers. Not all SIEFs have a consortium and not all members of the SIEF need to be part of a consortium.

The Directors’ Contact Group, an informal group of the European Commission, ECHA and some European industry associations, has published advice on points you should consider when looking at joining a consortium or just being part of the SIEF. Further information is available here.

6. What do I have to do if my substance has already been registered?

If your substance has already been registered, you should contact the lead registrant as soon as possible and discuss buying a Letter of Access. This will ensure you are part of the joint submission and be the proof of your right to refer to the data in the lead registrant’s dossier.

If you have pre-registered, it is likely that you have already heard from the lead registrant. Otherwise, you should check the pre-SIEF pages of REACH-IT and ECHA’s database of registered substances.

As co-registrant, your submission does not need to include the information already provided by the lead registrant. But be aware that, although much of the work has already been done, your own dossier needs to include information specific to your company, so preparing and submitting it will still require some time and resources.

7. What if my substance has not yet been registered? If the substance has not been registered, you should contact other potential registrants as a matter of urgency. If you pre-registered, ECHA will have automatically added you to the “pre-SIEF” webpage, which contains the contact details of all the companies that pre-registered that substance. If companies can agree they are all talking about the same substance, a SIEF can be formed and work can begin to prepare the joint registration dossier. Discussions on substance identity may see some pre-SIEFs merge or split. Decisions need to be clearly documented and justified in both situations, as they might be subject to enforcement.

If no one company is opening contact, you should consider doing so as soon as possible and think about whether to offer to act as lead registrant. Being a lead registrant gives you the chance to keep the registration under control, but it comes with the responsibility of leading the registration for your fellow SIEF members.

Lead registrants and candidate lead registrants should notify themselves to ECHA, which regularly updates the list of active lead registrants.

8. What are the information requirements if I manufacture/import 1-10 tonnes

a year?

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Minimum information requirements are outlined in Column 1 of Annex VII of REACH. These include a number of physicochemical data, as well as toxicological and eco-toxicological information. An overview can also be found on the ECHA guidance on registration (pages 55-57). If you are registering a substance in this tonnage band you will not need to prepare a CSR.

If the substance does not have a dispersive or diffuse use, and it is unlikely to be classified as having human health or environmental hazards, you only need to submit physicochemical data. To benefit from these reduced registration requirements you need to document your assessment carefully, for example by including available and reliable information on properties relevant to the classification and/or uses. ECHA is planning to publish some further guidance on this topic soon.

9. What are the information requirements if I manufacture/import 10-100

tonnes per year? Minimum information requirements are outlined in Column 1 in Annex VII and VIII of REACH. You need to have more toxicological and eco-toxicological information then you would for the lowest volume (1-10 tonne) substances. You will also need to conduct a CSA and present the results in the CSR. For the CSR, you need information on the manufacturing processes (but not for imports), identified use and exposure. Identified uses include your own use, those that you market a substance for and those that are made known to you by your customers and any subsequent customers further down the supply chain.

10. When should I start work on a registration dossier? Although 2018 may seem a long way off, companies should start work early. If you leave most of the work to 2017, the workload could be too large and may result in you missing the deadline to register. In addition, you may need to contract out some testing to get data for your registration. Tests take time and the testing houses may become overbooked the closer the deadline becomes. If you are a first-time registrant, it is advisable to have a plan in place to identify priorities and establish a timeline.

11. Who needs to be involved? Pulling together a registration dossier can be challenging and requires a wide range of expertise. You may need to involve regulatory affairs managers, toxicologists, occupational hygienists and legal advisers, amongst others. Procurement and sales also have a role in gathering data from suppliers and customers. All the expertise needed may or may not be already available within your company. You might also wish to hire consultants to help you preparing for registration. Resource needs will be highest for those who play an active role in preparing the joint submission dossier, but even those with a less active role need to ensure they have sufficient resource dedicated to REACH well in advance of the deadline.

12. How much will registration cost and how will these costs be shared? The total cost of registration varies depending on a number of factors, including the type of substance, the cost of the studies needed, the tonnage band of the substance you manufacture or import, the size of your company, and the number of registrants involved. It is therefore difficult to predict exactly.

Each registrant must pay a fee to ECHA for each individual registration dossier. ECHA fees are detailed here. The level of the ECHA fee depends on the type of dossier, the tonnage band of the substance, and some other factors. There are reduced fees for companies meeting the EU SME definition. Please note that the EU SME definition is different from the one sometimes used in the UK. Staff headcount, annual turnover, annual balance sheet are key criteria to assess SME status. You also need to consider ownership, voting rights and relationships with other companies. ECHA checks the SME status of any firms claiming this discount, and administrative charges apply if the

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claim is incorrect. It is therefore very important that you make sure your company fully meets the SME criteria. Step by step instructions on how to work out the right company size category are available here.

ECHA registration fees are only a small fraction of the total costs. Information gathering costs will be shared among the companies in a SIEF and, as a general rule, co-registrants need to compensate the lead registrant for the work they do (or have already done) putting the lead dossier together. This may relate to the running of tests or bringing in the support of consultants. Costs significantly increase if a CSR is required. Data sharing agreements should reflect these various costs in a transparent manner as set out by the implementing legislation on data sharing, recently adopted by the Commission with Member States and due for imminent publication.

It is important to note that companies should only pay for the data they need for their own registration and for a fair and transparent contribution for the preparation of the joint part of the dossier and to the SIEF administration costs. For instance, if you manufacture or import a substance in quantities between 1-10 tonnes a year, the data you need is generally limited to what is needed for that tonnage band (Annex VII). However, registration strategies sometimes may mean that higher tonnage data (Annex VIII upwards) are used to justify waiving some of the Annex VII requirements. This should be set out clearly in the SIEF costs.

Bear in mind that costs may be significant even for low tonnage registrations and sometimes it may be difficult to agree on what “fairness” means in practice. Advice on fair, transparent and non-discriminatory cost sharing in SIEFs is available on the Directors’ Contact Group webpage on the ECHA website.

13. What can I do if I do not agree with the costs? Although REACH does not foresee any role for ECHA in the management of SIEFs, it is possible to lodge a data-sharing dispute with ECHA if data or cost-sharing negotiations fail in SIEFs. You might find it helpful to read ECHA’s practical advice on data sharing negotiations, the ECHA’s Frequently Asked Questions on this topic and review the decisions on data and cost-sharing disputes taken so far by the Agency.

REACH allows a company to submit part of the information separately under certain conditions if joint submission of those pieces of information would lead to disproportionate costs or disclosure of commercial sensitive information, or if the co-registrant disagrees with the Lead registrant’s selection of data. In each case you need to explain why you have opted out. Co-registrants who opt out, however, must still submit their registration as part of the joint submission in line with the “One Substance, One Registration” requirement. Note that if you do decide to opt out, you will not benefit from reduced ECHA registration fees for joint registrations and ECHA will prioritise your dossier for evaluation.

When working with other companies and competitors remember that lengthy negotiations over costs, maybe involving legal support, may be in themselves expensive and time consuming, especially in large SIEFs. What you save in data sharing could be absorbed by legal, accounting or management fees, travel expenses and time negotiating in meetings. Reaching an amicable compromise with the other registrants should result in the best collective outcome in terms of time and money, and help you to meet REACH’s deadlines.

14. How can I avoid using animals when carrying out tests? Avoiding unnecessary animal testing is a major objective of REACH, and accordingly, animal tests should only be considered only as a last resort. Progress has been made in recent years to reduce the numbers of animals used during testing and in vitro (non-animal) test data is now widely accepted in many cases. However, there are still times when use of animals is unavoidable for

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regulatory assessment. When preparing a registration, you should observe these key principles to minimise animal testing. You should follow them in order: 1. The SIEF should consider all available existing information before concluding that there is an

information gap;

2. The SIEF should consider whether it can minimise animal testing by following one or more specific testing adaptations. These are shown in column 2 of the REACH annexes VII and VIII for substances manufactured or imported in a quantity up to 100 tonnes a year;

3. If REACH does not mention specific adaptations, SIEFs should consider whether animal testing can be minimised or avoided through other means (e.g. read across from a similar substance, weight of evidence assessment, QSARs (models used to predict the properties of chemicals), in vitro methods, etc.). These are outlined in Annex XI of REACH;

4. If adaptation is not possible and you cannot avoid animal testing, SIEFs must make sure they use the test of least severity and/or which uses the fewest animals. That is the test expected to cause the least pain, suffering, distress and lasting harm.

The UK REACH Competent Authority has developed useful guidance on opportunities to minimise animal testing, including for low volume registrations.

ECHA has also produced a guide on avoiding unnecessary animal testing and has more information, including details of new alternative testing methods, here. Finally, you should remember that any alternative testing strategy needs to be scientifically robust and clearly justified. ECHA may evaluate your registration dossier at a later stage, so it is important that you properly document how you have reached your decision. The annual ECHA evaluation reports offer some tips on how to substantiate your decisions.

15. What happens if I miss the 2018 deadline? “No data, no market” is one of the basic principles of REACH. So if you do not register a substance with the required information in time, you cannot manufacture or import it at volumes of 1 tonne or more per year. If you miss the deadline, you will have to register your substance before being allowed to restart manufacture or import. Selling unregistered chemicals after the registration deadline may be considered a breach of REACH and may also lead to backdated fines. Information on how the REACH enforcement regime operates in the UK is available on the UK Health and Safety Executive (HSE) website.

16. What happens once I have submitted my registration dossier? ECHA will send you an electronic invoice for your registration fee through REACH-IT. If you do not pay your invoice within the deadlines set by ECHA, your registration will be deemed incomplete in the completeness check. Dossiers are also checked for completeness for the required information. Once your dossier is judged complete and the fee paid, you will receive a registration number. All correspondence from ECHA about the registration is through your REACH-IT account, so it is important that you check it regularly and react promptly, if necessary.

Once you have got your registration, your job is not over and done with. It is your responsibility to make sure your dossier is kept up-to-date. It is important to have a review procedure to maintain knowledge of your substance and its uses. You should then update the dossier as new information emerges, for example, if new data or arguments to waive testing emerge that have a bearing on your substance. Do not forget that ECHA evaluates a proportion of registrations in detail and they may request further information on the substance at a later stage.

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If there is new hazard information, or information that may affect the risk management measures, you will also need to update any Safety Data Sheets, so customers are aware and can continue to use the substance safely.

17. What can I do if I’m relying on others to register a substance I depend on? Even if your company does not have to register, you may rely on some chemicals, so you need to make sure they will still be available. It is important to note that some manufacturers and importers may decide not to register their substances, and withdraw them from the market instead. This may be because of the costs of registration and/or because they fear substance may be subject to authorisation or restriction under REACH in future (these are the ways REACH can put extra controls on the most hazardous substances). It is therefore important to engage fully and early with your suppliers to understand their registration intentions. Otherwise, there is a very real risk that you may only discover after 2018 that a substance you use was not registered. Bear in mind that pre-registration is not a guarantee that the company will go on to register a substance.

UK Chemicals Stakeholder Forum – Annual Report 2015

Fig.3. Communication in the supply chain: general overview of downstream users’ rights and obligations

(Please consult the ECHA guidance for downstream users for a more detailed overview)

UK Chemicals Stakeholder Forum – Annual Report 2015

To address this risk, ask your supplier well in advance of the 2018 deadline whether they intend to register. You should also ask your supplier if they have established use and exposure categories/scenarios covering your use at least one year before the 2018 deadline. You can help to protect yourself by taking a proactive role and provide them with information to help them register. In the past, large companies with significant need of certain substances have helped smaller companies to register in order to guarantee future supply.

If you and/or your supplier’s operate in an organised sector, it is advisable to manage these contacts through the sector organisations. ECHA, industry associations and the Member States are cooperating to further develop tools to manage use information flows for registration as part of the “ECHA CSR/ES Roadmap ”. In organised supply chains, it should be expected that typical uses of the downstream user sector will be covered in registrations. Figure 3 gives you a general indication of the actions you should consider in terms of supply chain communication.

18. What can I do if my supplier says they won’t be registering a substance on

which I depend? If your supplier doesn’t register, he won’t be allowed to manufacture or import the substance at

volumes of 1 tonne or more a year. You should therefore consider to research alternative suppliers

who are available to register the substance and cover your use in their registration dossier. On

request, ECHA used to give downstream users’ contact details to any firms that identified

themselves as potential registrants. If you cannot find any suppliers available to register, your

company itself could look to manufacture or import the substance, and register it (if you reach the 1

tonne a year threshold). Remember that you could be entitled to submit a late pre-registration to

avoid a break in supply. If this is an option you decide to pursue you need to create a REACH IT

account.

Note: if a company doesn’t register by 31 May 2018 and ceases manufacturing or importing the substance, it

may still supply stocks, provided it had a valid pre-registration. Please see ECHA Q&A [40] for further

information.

19. What happens if my use is not covered by the registration? If you use a substance in a novel way that you think your suppliers may not expect, then you should let them know. It is possible that the registrant is covering your use, but it is safest to make sure. Here individual contact with your supplier would probably be the most efficient way forward. In some instances, you may only realise that your use hasn’t been covered by your supplier when you receive a revised safety data sheet after registration. If this happens, you have five options:

(i) Speak to your supplier and ask them to cover your use; (ii) Change your conditions of use to one covered by the safety data sheet; (iii) Substitute the substance with a different one that covers your conditions of use but where an exposure scenario is not required or available. Alternatively, substitute a different process which does not require the substance; (iv)Change supplier to one whose safety data sheet covers your use; (v) Prepare a downstream user CSR yourself, unless exemptions apply.

Under option (V), you might be required under certain circumstances to report information about your use to ECHA. In this case, you have six months to do so after you receive the safety data sheet containing the substance’s registration number.

UK Chemicals Stakeholder Forum – Annual Report 2015

Please note that if suppliers cannot support requested uses for reasons of protection of human health and the environment, they must inform ECHA (usually by updating the registration dossier) and downstream users in writing outlining the reasons.

20. What if I don’t want to tell my suppliers how I use their chemicals? If you don’t want to let your supplier know about a particular use (for example because of commercial concerns) then you don’t have to, but you will need to inform ECHA and possibly prepare your own chemical safety assessment. And finally...How to find out more You may be able to find out more about registration by contacting sector organisations, which may

be coordinating or signposting relevant activity or may have developed guidance specifically for your

area of business. The UK Competent Authority provides a REACH helpdesk. The helpdesk service is

free and confidential and can be contacted at UKREACHCA@hse.gsi.gov.uk.

There are also a number of guidance documents and materials available that you may find helpful:

ECHA REACH 2018 webpage;

To refer to the Annexes mentioned in the paper see the Regulation itself ;

HSE bite-size guidance on registration;

ECHA registration guidance in a nutshell;

Full ECHA guidance on Registration;

ECHA downstream users’ guidance in a nutshell;

ECHA Registration FAQs;

CEFIC guidance documents and tools for REACH implementation;

This guidance was drafted by a sub-Group of the UK Chemicals Stakeholder Forum comprising:

Susanne Baker (EEF, the Manufacturers’ Organisation) (Chair), Jo Lloyd (formerly Chemical Industries

Association), David Santillo (Greenpeace), Silvia Segna (Chemical Industries Association) and Glenis

Wedzicha (National Federation of Women’s Institutes). Non-Forum members - Keith Bailey (Defra),

Patrice Mongelard (Defra) and Jane Kirk (HSE) - also contributed to this work.

While we have made every effort to ensure that the information provided in this document is accurate and up to date, no legal responsibility is accepted for any errors, omissions or misleading statements. We accept no responsibility or liability whatsoever with regard to the information in this document. In principle, this information is not professional or legal advice. If you need specific advice, you should always consult a suitably qualified professional.

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex E: 2015 review of the UK Chemicals Stakeholder Forum2

11 December 2015 – 31 January 2016

1. Background

1.1 The UK Chemicals Stakeholder Forum (UKCSF) was established in the wake of the 1999 UK Chemicals Strategy (Sustainable Production and Use of Chemicals), and held its first meeting in October 2000. The Forum does not have the same formal status as a Non Departmental Public Body, or an expert scientific advisory body like the Hazardous Substances Advisory Committee. It is, however, a formally constituted body with appointed members and Terms of Reference. Defra provides the Secretariat for the Forum, and meets all costs associated with its meetings, about £15K a year. This excludes the cost of the Secretariat, and of other Defra staff and UK REACH Competent Authority staff, who contribute actively to the Forum.

1.2 The UKCSF is Defra’s main vehicle for structured external stakeholder engagement on chemicals. It currently has 24 members drawn from industry, environmental and animal protection and conservation organisations, trade unions and the scientific community, and an independent Chairman, Professor David Phillips (Emeritus Professor of Chemistry, Imperial College). Forum meetings are quarterly, and open to members of the public. Forum papers, minutes and presentations are published on its website. The specialist chemical press attend regularly, as do the UK REACH Competent Authority, Environment Agency, and BIS. The UKCSF will be holding its 63rd meeting on 26 January 2016.

1.3 The Forum was formally reviewed in early 2004, by public consultation. Of the four options presented the one that was selected, the Government’s stated preference, and the choice of the majority of the forty-six respondents was Option A:

Continue with the current UK Chemicals Stakeholder Forum, but refocus its activity with an additional advisory role to Government on current and future REACH discussions. The Forum would also move away from detailed examination of individual substances of concern towards encouraging more rapid industry action on substances in groups on its list of chemicals of concern.

1.4 The Forum’s terms of reference were revised between 2007 and 2008. The current terms of reference are at Annex A.

1.5 In recent years the Forum has operated a light touch, and mainly internal, annual review process centred around five questions for its members:

(a) Do you think the Forum is doing the job it is designed to do in relation to its Terms of Reference? Please comment on the different elements of the ToR.

(b) Are there any changes you would like to propose for the Forum and the way it works, i.e. ToR, membership, agenda, presentations, conduct of meetings?

(c) Is there anything you would like the Forum to do in the coming year?

2 The findings of this review and the way forward were discussed at the 64th UKCSF meeting in April 2016 – see paper UKCSF/16/16.

UK Chemicals Stakeholder Forum – Annual Report 2015

(d) What can you do to help the work of the Forum and raise its profile? (e) Is there anything else you wish to add that is not covered in Questions 1-4

which you feel is relevant to the purpose of this review?

Responses to these questions have been reported at Forum meetings regularly but have tended to be limited.

The Review context

2.1 Defra is committed to a far-reaching programme of reform, looking for the best and most effective way of delivering its outcomes. It will become a leaner, more effective, more strategic organisation, working to a single plan and focused on delivering its priorities. It will become more digital and data driven – with shared back-office functions. It will put its customers first; reducing burdens and devolving delivery to others where possible. Defra has also recently launched the #OpenEnvironment process to develop a new 25 year plan for the environment. To develop and deliver this it will need to make the best use of its resources, and also empower its stakeholders so they can work with it to achieve continuous improvement, integrated decision making and the environmental and growth outcomes we all seek. In the light of this programme of reform and of the Spending Review settlement (e.g. a 26% reduction in its administration budgets), Defra considers that the time has come for a formal and fundamental review of the UKCSF.

2.2 We need to find even greater value in what the UKCSF does, because of other competing high value activities which draw on Defra resources. This review should therefore take account of the evolution of the chemicals regulatory landscape, the relevance of the Forum’s input and outputs, its membership, work programme, the engagement of members with that programme, as well as chemicals supply chain initiatives and policies.

2.3 The Forum is clearly successful in bringing stakeholders together, providing a mechanism for exchanging views, creating a shared understanding, and producing some useful outputs such as guidance on major REACH aspects like Authorisation and Registration. However, the passage of time, changes in the wider landscape and the evolutionary process for greater efficiency of operation – require a degree of change.

2.4 Defra, the Devolved Administrations and the UK REACH Competent Authority share the view that the Forum serves a useful purpose, and that it should continue to operate. However, there are a number of ways in which it could be reformed, and Defra wishes to invite views on a range of possibilities.

Review ideas for consideration

3.1 The Terms of Reference (ToR) would continue to be owned by Defra and the Forum would continue to be accountable to Ministers. However, the ToR need to be a shared understanding between Defra and the stakeholders represented on the Forum. We are not suggesting that the Terms of Reference (ToR) need to be completely recast but these could be refined, perhaps to better recognise what the Forum is able to do. In practice, not all of the elements of the ToR are being served

UK Chemicals Stakeholder Forum – Annual Report 2015

equally, and some of the elements could be combined, whilst still retaining the triple thematic areas of REACH, international chemicals management and the chemicals supply chain. It may even be worth putting extra emphasis on particular areas where the Forum could do useful work. Defra would welcome views on how the Forum’s ToR could be fine-tuned to better reflect and recognise the Forum’s capabilities, whilst retaining their current orientation. Are there particular activities, or areas of work, which the Forum could take on to increase its value?

3.2 Defra has clear expectations about attendance at meetings. Meeting dates are set long in advance and we encourage attendance by deputies. On the whole attendance is good but not optimal at each meeting. So we need to find ways of improving this aspect. For example there could be a case for having fixed term appointments (currently appointments are open-ended) for 3 years, with re-appointment based on performance. Equally, members who miss two out of four meetings in any twelve month period should be invited to re-affirm their commitment to the Forum, or recognise that their priorities have changed. It could also be worth operating a waiting list for membership of the Forum. Defra would welcome views on how the membership of the Forum could be reformed to make it more effective, whilst retaining the current tripartite balance of industry, NGO and “learned societies”? Defra would also welcome comments on what could be changed in the way the Forum works to make it function more effectively, including delivering greater engagement from members. Views would also be welcome on the idea of having a smaller Forum, of twelve full members on fixed 3-year appointments (which may include new interests not currently on the Forum); and a cohort of supporting, but less influential, Associate Members?

3.3 As noted above there are real and competing pressures on Defra budgets and expenditure on the Forum is no exception. Defra would be interested in views on how it could reduce the costs of the Forum, for example should Forum members continue to be eligible claim travel costs for attending meetings, or should the interests they represent pick up this cost, given the benefits which they derive from membership of the Forum? Views are also invited on other measures such as Forum members hosting meetings in rotation? Should the frequency of meetings be reduced – and if so how many meetings would members deem to be a minimum requirement for the Forum to be effective? Taking a more innovative stance, would Forum members be willing to consider the possibility of making an annual contribution to the cost of running the Forum, for example via a membership fee, which could be modulated further for full and associate members?

3.4 More broadly, it is for consideration whether Defra should put in place a different business model for stakeholder engagement on chemicals issues. Defra is satisfied with the current and long-standing mechanism for the Forum to have an independent Chairman. However, there are other stakeholder engagement models where Chairmanship is rotated between members, or where Defra itself chairs the body in question. It is assumed that the location of the Secretariat should continue to rest with Defra, and the access this provides to the UK REACH Competent Authority and other Departments, and to a dedicated website with a .gov.uk badge.

UK Chemicals Stakeholder Forum – Annual Report 2015

It is unlikely that any individual Forum member would be able to commit the same level of resources as Defra to running the Forum, and with the same degree of balance, and openness. However Defra is open to alternative suggestions on these broader issues. We would welcome views on broad changes which members and others would wish Defra to consider, relating - for example - to the Chairmanship of the Forum, the Forum’s ways of working including open meetings and the Forum website, the Forum’s relationship with Defra and HSE officials and with Ministers? What is it that Forum members and others value about the Forum, which they would wish to see carried over into any alternative arrangements?

Timetable

4.1 Respondents listed at Annex B have a period of six weeks to offer comments. Forum members, as well as the wider community of interests who have attended Forum meetings regularly in the past calendar year or so, are invited to respond to this review paper. The paper will also be signposted on the UKCSF website - https://www.gov.uk/government/groups/uk-chemicals-stakeholder-forum. This may generate further responses. It is intended that all the responses, and a Defra position, will be discussed at the Forum meeting due to be held on 26 April 2016.

4.2 The deadline for responses is Friday 29 January 2016. Responses should be emailed to the Forum Secretary Patrice Mongelard, at:

patrice.mongelard@defra.gsi.gov.uk

4.3 Defra will publish a summary of comments received, as well as its response to these comments, in due course, in particular after taking account of the views of Defra Ministers.

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex A: UK Chemicals Stakeholder Forum Terms of Reference

The purpose of the Forum is to advise Government on managing risks to the environment and to human health via the environment that may result from the production, distribution and use of chemicals. Recognising the changing circumstances in which chemicals are regulated, the Forum aims to be a strategic body, paying due regard to the promotion of sustainable consumption and production throughout the chemicals supply chain, to the life cycle of chemicals, to the precautionary principle, and to the need to add value and not replicate activities undertaken elsewhere.

In particular it will:-

review the effectiveness of REACH in realising its goals in the light of the experience and needs of UK stakeholders;

review the effectiveness of the UK Competent Authority in delivering its obligations under REACH, and engage it in an on-going dialogue to reflect stakeholder views and concerns;

advise Government on measures to promote the sound management of chemicals internationally;

continue to promote voluntary action by industry in the UK where this can make a contribution to a reduction in the overall use of those substances recognised by the Forum as being priorities for action;

communicate and encourage best practice and innovation, and encourage others to do so;

promote more effective linkages throughout the chemicals supply chain, and between all those with an interest in the future of a sustainable and competitive UK chemicals industry.

In order to measure the effectiveness of the activities above as they relate both to itself and others, the Forum will develop key performance indicators against which it can assess performance.

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Annex B: Consultation list

UKCSF Members

ADS (UK Aerospace, Defence, Security and Space industries) Cathy Phillips British Association for Chemical Specialities John Reid British Coatings Federation Tom Bowtell British Plastics Federation Philip Law British Retail Consortium David Bolton Business Council for Sustainable Development – UK Pat Laughlin Chemical Business Association Michael Cooper Chemical Industries Association Nishma Patel Chemicals, Health and Environment Monitoring (CHEM) Trust Gwynne Lyons Cruelty Free International Katy Taylor EEF, the manufacturers’ organisation Claire Jakobsson Environmental Services Association Ray Parmenter Federation of Small Businesses Andrew Poole Green Chemistry Network James Clark Greenpeace David Santillo Knowledge Transfer Network Steve Fletcher National Federation of Women’s Institutes Glenis Wedzicha Non-Ferrous Alliance Piat Piatkiewicz Royal Society of Chemistry David Taylor Society of Chemical Industry Martin Elliott TechUK Susanne Baker Trades Union Congress Bud Hudspith UK Cleaning Products Industry Association Philip Malpass Mike Holland

Devolved administrations/Government Departments

Keith Bailey Defra REACH Team Douglas Bush Department for Business Innovation and Skills Morwenna Carrington Defra, Head of Chemicals Alastair East Department for Business Innovation and Skills Duncan Egerton Defra REACH Team Robin Foster HSE International Chemicals Unit Stavros Georgiou HSE Chemicals Regulation Directorate Richard Hawkins Environment Agency Barry McAuley Department for Environment, Northern Ireland Martin McVay Welsh Government Rob Morris Scottish Government Mike Potts HSE Chemicals Regulation Directorate Andrew Smith HSE Chemicals Regulation Directorate Richard Vincent Defra International Chemicals Other interests

Rebecca Barnett EUK Consulting

UK Chemicals Stakeholder Forum – Annual Report 2015

Tony Bingham Chemical Hazard Communication Society Steve Binks International Lead Association Nick Boley Laboratory of the Government Chemist Linda-Jean Cockcroft RPA Tess Crean Client Earth Mindy Dulai Royal Society of Chemistry Jon Edwards Royal Society of Chemistry Stephen Holgate Chairman Hazardous Substances Advisory Committee

Dale Iddon Eli Lilly and Company Steven Lipworth Royal Society of Chemistry Jo Lloyd ERM Simon Marsh Chemical Industries Association Sean McPike Eli Lilly and Company Mamta Patel Chemical Watch Steve Quinn West & Senior Geraint Roberts Chemical Watch Rachel Salvidge ENDS Report Silvia Segna Chemical Industries Association Wayne Smith British Coatings Federation Bill Watts Independent consultant

Susie Wilks Humane Society International

UK Chemicals Stakeholder Forum – Annual Report 2015

Annex F: Financial information The Chairman and other members of the UK Chemicals Stakeholder Forum (UKCSF) do not receive salaries. Forum members are not entitled to claim fees for the time they spend on Forum business. However, the Chairman can claim a daily fee for his work on the Forum. This covers attendance at meetings, as well as time spent on other Forum-related activities. All fees paid are taxable.

The Chairman’s fee is liable increased annually in line with recommendations from the centre. However, there was no increase in 2015. The fee, from April 2009, stood at £204/day.

All Forum members are entitled to claim reimbursement for costs incurred in travelling (standard class) to and from meetings, which are mostly held in London, including any necessary overnight stays, and for any necessary meals and refreshments covering the period of travel. All claims are based on actual costs and require supporting receipts, i.e. for hotels, meals, rail tickets, taxis, car parking etc. which are verified by the Secretariat.

In 2015 Defra paid out £1,020.00 in fees to the UKCSF Chairman. Defra reimbursed £2900.62 to UKCSF members in travel and subsistence costs in 2015.

The total cost of the UKCSF to Defra, in 2015 was £14,768.19, including the cost of facilities for quarterly meetings, other meetings and workshops, lunches, etc.