Documents considered by the Committee on 25 April 2018 Contents

4EU chemicals policy review

Committee’s assessment

Politically important

Committee’s decision

Not cleared from scrutiny; further information requested; drawn to the attention of the Environmental Audit and the Business, Energy and Industrial Strategy Committees

Document details

Commission Communication—Commission General Report on the operation of REACH and review of certain elements: Conclusions and Actions

Legal base

Department

Environment, Food and Rural Affairs

Document Number

(39540), 6916/18 + ADDs 1–7, COM(18) 116

Summary and Committee’s conclusions

4.1The core of EU chemicals policy is the “REACH” (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation.37 This was adopted in 2006 to improve the protection of human health and the environment from the risks that can be posed by chemicals. It included the establishment of the European Chemicals Agency (ECHA), of which the Prime Minister has said the UK intends to seek associate membership post-Brexit.38

4.2The Commission’s document is the second five-yearly review of the Regulation. It concludes that REACH is effective but there are opportunities for further improvement, simplification and burden reduction. A number of proposed actions are identified, as set out below. These are of a non-legislative nature as it was concluded that the legal requirements remain fit for purpose.

4.3The Parliamentary Under Secretary of State for the Environment (Dr Thérèse Coffey) does not refer to the Prime Minister’s commitment to seek associate membership of the ECHA, but she does confirm that UK manufacturers and distributors exporting chemicals to the EU will have an interest in any changes to the implementation approach in REACH. She also confirms that UK officials will be seeking to influence follow-up actions and activities, with a particular focus on embedding better regulation approaches via simplification measures.

4.4The Minister states that UK officials remain engaged in EU decision-making forums “and are working hard” to maintain relationships and policy outcomes that ensure protection for human health and the environment, and maintain the UK’s reputation for excellence in scientific analysis and evidence-based regulatory policy-making.

4.5We welcome the continued engagement of UK officials in EU decision-making forums, working hard to maintain relationships and policy outcomes even as the UK negotiates its withdrawal from the EU.

4.6We are surprised, however, that the Minister does not reference the Prime Minister’s intention to seek associate membership of the European Chemicals Agency post-Brexit. While the outcome of negotiations is unknown, we believe that the Prime Minister’s objective is an important consideration in the UK’s approach to the various actions proposed.

4.7The Prime Minister was asked at the House of Commons Liaison Committee meeting on 27 March 2018 what associate membership of ECHA would look like in practice. In response, she referred to Switzerland’s membership of the European Aviation Safety Authority (EASA) and also said that the objective of ECHA associate membership would be to ensure that there would be only one set of approvals for access to UK and EU markets. She was otherwise imprecise in terms of the UK’s vision for associate membership of ECHA.

4.8Following the example of Swiss participation in EASA, however, and the logic of requiring only one set of approvals, it would seem reasonable to assume that the UK would apply relevant legislation, in the same way as the Swiss implement EU aviation safety legislation.39 We ask whether this is a reasonable assumption and whether the Government envisages that any such application would extend to the other Regulations covered by ECHA—i.e. Biocidal Products Regulation, the Classification, Labelling and Packaging (CLP) Regulation and the Prior Informed Consent Regulation.

4.9We note that one of the areas covered in the Commission’s report is that of the future role and funding of ECHA, given that ECHA’s income from fees post-2020 will reduce substantially because the number of registrations will drop significantly. In the light of the commitment to seeking associate membership of ECHA, we would welcome the Minister’s view on the Commission’s assessment of the future role and funding of ECHA and how the issues identified might be addressed.

4.10We retain the document under scrutiny and draw it to the attention of the Business, Energy and Industrial Strategy Committee in the light of its work on the implications of Brexit for the pharmaceuticals sector and to the attention of the Environmental Audit Committee given its interest in the future of chemicals regulation.

Full details of the documents

Commission Communication—Commission General Report on the operation of REACH and review of certain elements: Conclusions and Actions: (39540), 6916/18 + ADDs 1–7, COM(18) 116.

Background

4.11REACH puts obligations on industry to collect chemical safety information, to use this information to develop and apply appropriate risk management measures, to communicate these measures to users of chemicals and, finally, to document this in registration dossiers submitted to the European Chemicals Agency (ECHA).

4.12ECHA or Member States evaluate if the safety information is sufficient and, if not, require additional information. REACH also establishes two distinct EU risk management approaches: a) Restrictions enable the EU to impose conditions on the manufacturing, placing on the market or use of substances; b) Authorisation is designed to ensure that substances of very high concern (SVHCs) are used safely while promoting substitution by suitable alternatives.

Achievement of REACH Objectives

4.13REACH first came into force in June 2007, and today it is fully operational and delivering results towards achieving its objectives. REACH has influenced legislation in third countries (such as South Korea and China), highlighting the potential for it to serve as a global model for chemicals legislation. The cost of REACH to businesses and regulators is estimated at £2–2.3 billion. However, the estimated benefit to human health and the environment is £88 billion over 25–30 years. A number of improvements are suggested (see below).

Industry responsibility

4.14Industry (manufacturers and exporters) have generally completed their registration dossiers on time for existing substances, and measures to support SMEs to meet their registration obligations have been effective. More work, however, needs to be done in filling important data gaps and companies therefore need to be incentivised to update their registration dossiers. Compliance with EU information requirements by registrants was considered insufficient due to the use of alternative methods to animal testing and inconsistencies in hazard assessment between registrants and regulatory authorities. Information passed through the supply chain has increased, though this could be achieved more efficiently, further reducing costs and especially benefitting SMEs. REACH has, however, stimulated the development of alternative substances, to be used as substitutes for more hazardous chemicals, compared to previous legislation.

Action by Member States and the Commission

4.15The review highlighted insufficient resources in Member States to participate in risk assessment and regulatory proposals. Despite improvements, further work is needed to reinforce national enforcement activities. Discrepancies were established between REACH and other EU legislation that the Commission needs to address. In addition, the ongoing regulatory gap relating to information needs for nanomaterials is currently being addressed by proposed amendments to the REACH Annexes.

European Chemicals Agency (ECHA)

4.16ECHA has been instrumental in the implementation of REACH and has built up significant competence in chemicals management by enabling stakeholders to easily access the world’s largest database on chemicals. It has also established scientific cooperation with a number of EU and non–EU agencies. However, ECHA’s income from fees post-2020 will reduce substantially because the number of registrations will drop significantly. The Commission has committed to assessing how ECHA’s independence and expertise can be maintained.

Proposed actions

4.17The Commission proposes sixteen actions, to be undertaken by the Commission, ECHA, Member States and industry:

The Minister’s Explanatory Memorandum of 29 March 2018

4.18The Minister explains that the Commission is now opening discussion with stakeholders on implementation of its proposed actions. The UK will, she says, be seeking to influence follow-up actions and activities. The Minister adds:

“UK officials remain engaged in EU decision making forums, and are working hard to maintain relationships and policy outcomes that ensure protection for human health and the environment, and maintain the UK’s reputation for excellence in scientific analysis and evidence based regulatory policy making.”

4.19Concerning the content of the review, there are certain aspects that the UK particularly welcomes, such as the importance of closing the regulatory gap in REACH for nanomaterials. More broadly, says the Minister, the UK will use the review to further embed better regulation approaches via simplification measures, reducing costs for business and SMEs in particular. Specific proposals which could be fruitful in furthering a better regulation approach might include (but not be limited to):

4.20The Minister notes that the review highlighted issues around insufficient resources in Member States for scientific evaluation, which reduces the overall EU activities in assessing and regulating substances. The UK, says the Minister, has been a leader in this area, and has put forward a number of regulatory dossiers.

4.21On the UK’s withdrawal from the EU, the Minister writes:

“In light of the UK’s departure from the EU, UK manufacturers and distributors exporting chemicals to the EU will have an interest in any changes to the implementation approach in REACH. Those operating in the UK will also have an interest, as REACH will be brought into UK law under the Withdrawal Bill as retained EU law, although the changes proposed in the review are non-legislative.”

Previous Committee Reports

None.


37 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

38 Mansion House speech, 2 March 2018.

39 Article 66 of the EASA Regulation (Regulation No 216/2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency) provides for participation of European third countries in EASA on condition that they apply Community law in the field covered by the Agency, including implementing rules.




Published: 1 May 2018