Documents considered by the Committee on 9 May 2018 Contents

6Workplace safety: amendments to the Carcinogens and Mutagens Directive (Phase II and Phase III)

Committee’s assessment

Politically important

Committee’s decision

Not cleared from scrutiny; drawn to the attention of the Health Committee and the Work & Pensions Committee

Document details

(a) Proposal for a Directive amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Phase II); (b) Proposal for Directive amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Phase III)

Legal base

(a) and (b) Article 153(2) TFEU; ordinary legislative procedure; QMV


Health and Safety Executive

Document Numbers

(a) (38447), 5251/17 + ADDs 1–3, COM(17) 11; (b) (39612), 7733/18 + ADDs 1–3, COM(18) 171

Summary and Committee’s conclusions

6.1Cancer is the leading cause of work-related deaths in the EU, accounting for 53% of the total. In the UK alone, around 3,500 people die each year from occupational cancer caused by exposure to carcinogenic substances, principally through inhalation. To reduce these numbers, the EU has legislation in place to prevent dangerous levels of workplace exposure to such substances in the form of the Carcinogens and Mutagens Directive (CMD).35 Since May 2016, the European Commission has put forward three separate sets of amendments to the Directive to further restrict the use of certain carcinogenic substances in the light of the latest scientific evidence (termed Phase I to III respectively).

6.2The substances now being added to the Directive have been discussed over several years in the Working Party on Chemicals (WPC), a sub-group of the EU’s Advisory Committee on Safety and Health at Work (ACSH). The UK is currently one of four Member State governments represented on the WPC, which issues opinions on appropriate limits and notations for carcinogenic substances. These were subsequently endorsed by the ACSH (where all Member States are represented), and formed the basis for the three sets of amendments that have been proposed by the European Commission. From 29 March 2019, the UK will no longer be represented on the WPC and the ASCH when it ceases to be an EU Member State.

6.3We last considered the Carcinogens and Mutagens Directive and the proposed amendments at our meeting on 31 January 2018. While Phase I has been formally adopted (and will take effect from 2020 onwards), the Phase II and III proposals to amend the CMD are still subject to negotiations between the European Parliament and the Member States in the Council.36

The Phase II proposal: exposure limits for engine oils, PAHs, diesel exhaust fumes and cytotoxic drugs

6.4The Phase II proposal would bring exposure to used engine oils within the scope of the CMD, and assign a skin notation37 to such oils. It would also add five specific carcinogenic substances to the list of chemicals covered by the requirements of the Directive, and set accompanying exposure limit values and a skin notation for each.38 The Member States provisionally approved the changes in June 2017,39 and also included new exposure limits for Polycyclic Aromatic Hydrocarbons (PAHs).40

6.5The Minister for Disabled People, Health and Work (Sarah Newton) wrote to the Committee on 24 April 2018 with information on the European Parliament’s position on Phase II.41 The Government views some of the Parliament’s amendments as problematic, notably those for calling for an exposure limit for Diesel Exhaust Emissions (DEEEs). The Parliament has proposed to introduce limits for two different materials present in such emissions (elemental carbon and nitrogen dioxide). These had been omitted from the original proposal due to “practical difficulties with measuring techniques and concerns about the legal clarity of a definition”.42 For this reason, the Government is opposed to its inclusion in the Directive “without the Commission providing assurances that” these technical obstacles “are no longer an issue”.43

6.6Similarly, the Minister notes that the Government opposes a proposal by MEPs calling on the European Commission to make proposals for exposure limits for cytotoxic drugs44 and other pharmaceuticals within the CDM,45 because this is “not supported by any specific evidence and at present the UK is not convinced that it is necessary to include such drugs within the scope of the Directive”. The Minister adds that the UK would need assurance that “any future inclusion would not impact on the availability and use of such drugs and would not have an adverse impact on treatments available to patients”.46

6.7The Member States and the European Parliament have scheduled three rounds of negotiations on the final text of the Phase II proposal before the 2018 summer recess. The Minister says the proposed addition of DEEEs “will be the predominant issue during trilogues”. The new Directive is likely to be adopted before the end of the year.

Phase III: cadmium, beryllium, arsenic acid, formaldehyde and MOCA

6.8On 5 April 2018 the European Commission published a proposal for a third phase of amendments to the Carcinogens and Mutagens Directive.47 This sets out occupational exposure limit values (OELVs) for five substances: cadmium, beryllium, arsenic acid, formaldehyde and MOCA.48 This amendment would also set a skin notation3 for MOCA, a notation for skin sensitisation49 for formaldehyde, and a notation for both skin and respiratory sensitisation50 for beryllium.

6.9The proposal contains a number of transition periods, which will delay the entry into force of the new exposure limits after they are agreed by the Member States and the European Parliament (beyond the normal two-year transposition deadline for most EU Directives and for this proposal as currently drafted). The transition is intended to reduce the impact of the changes on businesses by making it possible to anticipate the changes, gradually introduce improvements and plan necessary investments to meet the limits. Because of this, the Government expects the new exposure limits to take effect in 2021, 2024 and 2026 for arsenic acid, beryllium and cadmium respectively.

6.10The Minister submitted an Explanatory Memorandum on the Phase III proposal on 24 April 2018.51 In it, she “broadly welcomes” the new exposure limits, noting that current UK legislation already requires employers to consider “all routes of exposure to carcinogens to be considered, including skin” and ensure any exposure to carcinogenic substances are “controlled to as low a level as is reasonably practicable”. The new EU limits for the five substances affected by the latest proposal are lower than current UK limits, with the exception of MOCA (where the UK workplace exposure limit is already lower than proposed by the Commission).

6.11With respect to the implications of the Phase III proposal for health & safety legislation in the UK in the context of Brexit, the Minister says:

“The transition periods for these substances will extend beyond the end of the proposed EU exit implementation period, we will apply the same evidence-based rigour to our assessment of these proposals as we have to the other limits proposed in this, and previous amendments to the Directive. […] We are proceeding on the basis that these amendments to the CMD will need to be transposed into UK law as the likely date of coming into force of the proposal will fall before 31 December 2020.”

6.12It has since been clarified by officials that this reference to the “coming into force of the proposal” should be understood to be a reference to the transposition date of the proposed Directive.

6.13The exact timetable for adoption of the Phase III amendments by the European Parliament and the Council is uncertain at this stage, although as noted the Government believes the likely transposition date will be before the end of 2020.

6.14We thank the Minister for her latest update on the proposed amendments to the Carcinogens and Mutagens Directive. The Committee retains both the Phase II and Phase III proposals under scrutiny in anticipation of further information on the final legal texts and attendant implications for UK workers and businesses. We also draw these developments to the attention of the Health Committee and the Work and Pensions Committee.

6.15During the post-Brexit transitional period sought by the Government, and included in the draft Withdrawal Agreement, the UK will be under an obligation to implement any changes to the Carcinogens and Mutagens Directive if the transposition date falls during that period. As such, the Minister has previously confirmed that the Government is “proceeding on the basis that amendments to the CMD could be implemented despite their likely dates of application falling after March 2019 but stand ready to react swiftly to developments as they occur”.52 She has reiterated in her latest Explanatory Memorandum that the ‘Phase III’ changes now under consideration are also likely to require transposition in UK law before the end of the implementation period, regardless of the proposal’s own transitional provisions.

6.16With respect to the Phase II proposal, we note that the European Parliament has called for the inclusion of exposure limits for cytotoxic and other types of drugs in the Directive. The Government is opposed to any such measures, at least in the absence of assurances that this would not impact negatively on the availability of such pharmaceuticals for treatment of patients. We ask the Minister to provide further information on the possible implications of the inclusion of the Parliament’s suggestions into the CMD if it is retained during the trilogue process, especially in view of the fact that any further amendments to the Directive may be agreed at EU-level after the UK loses its institutional representation in March 2019 (and, possibly, have to be implemented in the UK if the relevant transposition deadlines fall during the post-Brexit transitional period).

6.17More generally, the Committee remains concerned about the implications of the post-Brexit transitional arrangement, as it will see the UK under a legal obligation to apply and, where required, implement EU law over which it will no longer have any substantive influence within the Council or the European Parliament. In the area affected by the Carcinogens and Mutagens Directive, the UK will lose its position on the Advisory Committee on Safety and Health, which has been the driving force behind the modernisation of the Directive. The Committee has already raised with the Government the question of oversight of the transitional arrangement by Parliament, in particular with respect to the functioning of the proposed UK-EU Joint Committee that will seek to resolve any disputes over the applicability or, where required, implementation of new EU law in the UK during that period.

Full details of the documents

(a) Proposal for Directive amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Phase II): (38447), 5251/17 + ADDs 1–3, COM(17) 11; (b) Proposal for Directive amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Phase III): (39612), 7733/18 + ADDs 1–3, COM(18) 171.

Previous Committee Reports

For Phase I, see: (37758), 8962/16: HC 71–iv Sixth Report (2016–17), chapter 6 (15 June 2016); Thirteenth Report HC 71–xi (2016–17), chapter 6 (12 October 2016); First Report HC 301–i (2017–19), chapter 29 (13 November 2017); and Twelfth Report HC 301–xii (2017–19), chapter 9 (31 January 2018).

For Phase II, see: (38447), 5251/17: Thirty-first Report HC 71–xxix (2016–17), chapter 9 (8 February 2017); Fortieth Report HC 71–xxxvii (2016–17), chapter 16 (25 April 2017); First Report HC 301–i (2017–19), chapter 29 (13 November 2017); and Twelfth Report HC 301–xii (2017–19), chapter 9 (31 January 2018).

There are no previous Reports on the Phase III proposal.

35 Directive 2004/37/EC, as amended.

36 The Phase I proposal was cleared from scrutiny on 13 November 2017 and subsequently published in the Official Journal as Directive 2017/2398/EU. The Committee has previously considered the recent spate of amendments to the CMD in its Reports of 25 April and 13 November 2017 and of 31 January 2018.

37 A skin notation assigned to a substance identifies the possibility of significant exposure through the skin which contributes to the total body burden of exposure, and consequently to possible health effects. This must be taken into account by employers when undertaking a risk assessment. For substances which cannot enter the body via the skin, the notation is absent.

38 The previous Committee considered the contents of the Phase II two proposal in more detail in its Report of 8 February 2017.

39 Although the European Scrutiny Committee had granted a scrutiny waiver in April 2017, the Government abstained from supporting the Council general approach because of the last-minute addition of PAHs to the scope of the Directive.

40 PAHs consists of a group of over a hundred substances released from burning coal, oil, wood, general waste and other organic materials. The Health and Safety Executive considers that the impact of extending the CMD to PAHs in the UK is likely to be low as exposure of a substance via any route, including the skin, “already needs to be considered as part of the risk assessment required by UK legislation”.

41 Letter from Sarah Newton to Sir William Cash (24 April 2018). See also European Parliament document A/2018/142.

42 In Great Britain, the Control of Substances Hazardous to Health Regulations (COSHH) already requires industry to put control measures in place to reduce exposure to a level that is proportionate to the health risk, including for DEEEs. Similar arrangements are in place for Northern Ireland and Gibraltar.

43 The Minister explains that DEEEs are a “complex mixture of a variety of substances”, meaning that “it is not possible to set a single limit for DEEEs in its form as a mixture of different substances”. The values presented by the European Parliament are for ‘markers’ for 2 different materials present in DEEEs—elemental carbon and nitrogen dioxide—and “both of them have their limitations as a measure of occupational exposure. They may be difficult for industry sectors, such as mining and tunnelling, to meet”.

44 Cytotoxicity refers to the ability of a drug to kill cells. Cytotoxic pharmaceuticals are used widely in cancer treatments, such as chemotherapy.

45 The European Parliament has proposed a new recital 3b to the Directive which would read: “Further amendments to that Directive should address the issue of exposure of workers to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs, including cytotoxic drugs, and work involving exposure to carcinogenic or mutagenic substances in cleaning, transport, laundry and waste disposal of hazardous drugs of materials contaminated by hazardous drugs and in personal care for patients under treatment of hazardous drugs.”

46 The Minister notes in her letter that “my officials are consulting with the Department of Health and Social Care on this proposed addition” of exposure limits for cytotoxic drugs to the Directive.

47 He Phase III proposal is contained in Commission document COM(2018) 171.

48 MOCA stands for 4,4’-Methylene-bis(2-chloroaniline). It is listed as a ‘substance of very high concern’ by the European Chemicals Agency.

49 A notation for ‘skin sensitisation’ is made where exposure to a substance can cause adverse skin reactions (in this case for formaldehyde and beryllium and its inorganic compounds).

50 A notation for ‘respiratory sensitisation’ is assigned where exposure to a substance by inhaling can cause adverse reactions in the respiratory tract (in this case beryllium and its inorganic compounds). Employers are under a legal obligation to take into account skin, skin sensitisation and respiratory sensitisation notations when performing risk assessments, and when implementing preventive and protective measures for a particular carcinogen or mutagen in accordance with the CMD.

51 Explanatory Memorandum submitted by the Health & Safety Executive on 24 April 2018.

52 Letter from Sarah Newton to Sir William Cash (17 January 2018).

Published: 15 May 2018