Progress update | Safer Chemicals

A progress update from HCWH Europe on EU chemicals regulation and legislation, and a look forward to 2017 for EU Mercury Regulation, Medical Devices Regulation, EDC criteria, and CETA.

EU Mercury Regulation

The European Commission presented its proposal for a regulation in February 2016, and on 6th December 2016 the presidency of the Council and the European Parliament reached an agreement on a compromised text. On 16 December 2016, the Permanent Representatives Committee (Coreper), endorsed the text on behalf of the Council.

For HCWH Europe, the main area of interest was on dental amalgam - Article 10 of the regulation. This agreement is to ban dental amalgam fillings for children under 15 and for pregnant and breastfeeding women as of 1st July 2018. The text, which must now be approved by both Parliament and Council, also requires each Member State to set a national plan by 1st July 2019 on how it will reduce amalgam use. The Commission will report by mid-2020 on the feasibility of phasing out dental amalgam (preferably by 2030) to be accompanied by a legislative proposal, if appropriate. In addition dental practitioners will be responsible for the conditioning and disposal of their waste and they expected to make sure that these stages are carried out in an environmentally sound manner. 

Next steps

After formal endorsement by the Council, the new piece of legislation will be submitted to the European Parliament for a vote at first reading and to the Council for final adoption.

On 12 January, the ENVI Committee voted on the text agreed during inter-institutional negotiations on the Regulation on Mercury. The Council is now able to finalise its approval of the measure (expected later in March), meaning that publication in the Official Journal and entry into force may occur before the summer of 2017. The Regulation on Mercury transposes the requirements of the Minamata Convention into EU law.

Medical Devices Regulation

The European Commission recently said that it expects to adopt its Regulation on medical devices by the end of May 2017. Annex I.2.7.4, of the medical devices Regulation includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic, and reprotoxic (CMR) substances and endocrine disrupting chemicals (EDCs) in devices that are invasive and come into direct contact with the body. This includes devices that (re)administer, transport, or store medicines, body liquids, or other substances, including gases, to/from the body. Devices would only be permitted to contain such substances at a level above this limit if a justification is provided.

Importantly, within a year of the Regulation’s entry into force, the Commission will provide a mandate for the relevant scientific committee to prepare guidelines on phthalates. This would include a benefit-risk assessment of their presence, as they are CMRs or EDCs, and such assessments would have to be updated within five years. The Commission would also issue similar mandates for the preparation of guidelines on other CMRs.

Annex II of the Regulations also includes labelling provisions: a label on the device and the packaging would have to say if the device(s), their parts or materials contain CMRs or EDCs above the concentration limit. A list of such substances must be included. 

The timetable for 2017 is as follows:

The Council of Ministers’ Permanent Representatives Committee (Coreper) and the European Parliament’s Environment Committee (ENVI) endorsed the texts in June last year. They will replace existing Directives and their provisions will apply three years after publication for medical devices.

  • 18-19 January: Experts meet to approve final text in English after lawyer-linguists (LL) verification
  • Mid-February: Completion of translation of other languages; text distributed;
  • 1 March: Coreper expected to endorse texts
  • 6 or 7 March: Council expected to give endorsement
  • 16 March: Announcement in Council plenary; first reading position and transmission to ENVI
  • 20-21 March: Announcement in ENVI and vote
  • 3-6 April: Plenary vote and signature expected
  • May: Enters into force.

The Regulations will be published in the Official Journal shortly after adoption and enter into force on the 20th day after this.

European Commission postpones vote on criteria for Endocrine Disrupting Chemicals (EDCs)

Vote on EDCs postponed

On the 21st December 2016, after years of debate and delay, EU Member States’ experts met in Brussels to discuss and potentially approve the drafts on identification criteria and a derogation allowing use of Endocrine Disrupting pesticides. However, the Commission eventually decided not to put their most recent proposals to an official vote, because they would not have obtained the sufficient qualified majority from Member States (read the 8th December version of the EDC criteria for Biocidal Products, the Pesticides Regulation, and the revised Pesticides amendment draft).

The next discussion and meeting on EDC criteria is likely to take place on the 15th February when EU Member States are to meet at the relevant expert committees. 

ECHA publishes draft guidance for identifying EDCs

On the 20th December 2016, the European Chemical Agency (ECHA) and the European Food Safety Authority (EFSA) published an outline of the draft guidance for identifying endocrine disrupting chemicals (EDCs).

This document explains what will be in the final guidance, covering areas such the type of data and information that may be considered sufficient to conclude on the endocrine disrupting properties of a substance in accordance with the criteria. 

Once completed, the draft guidance will be subject to a public consultation, which is expected to launch in June 2017 and run for two months. Following the consultation, a workshop will be held with Member State representatives who are experts in evaluating endocrine disruption to assess the applicability of the guidance. The outcomes will be published in a report.

The Unhealthy Side Effects of CETA

On the 28th October 2016, the Council adopted a package of decisions on the comprehensive economic and trade agreement with Canada (CETA). CETA is often billed as the most sophisticated trade agreement to date signed by the EU - it is ambitious and is presented as holding promises of economic growth.

CETA will remove more than 99% of tariffs that are currently imposed on trade between the EU and Canada; it claims to set high standards for consumer, environmental, and labour protection.

But a recent series of case studies: The Unhealthy Side Effects of CETA published by EPHA, highlighted the undesirable side effects for people and public policy making. They stress the negative effect CETA will have on public health by opening the door for businesses to challenge public health laws, limiting policy choices for Services of General Interest.

On the 12th January, the Environment Committee (ENVI) of the European Parliament (EP) voted in support of CETA, paving the way for a final EP vote in February 2017. HCWH Europe will again contact Members of the European Parliament to ask them to vote against CETA.