Synthetic chemicals play a major role in modern society, contributing to our well-being and comfort and providing a number of economic benefits. However, many chemicals also pose risks to human health and the environment. While regulatory frameworks are in place for managing and controlling unacceptable risks from chemicals – notably the REACH Regulation (EC 1907/2006) on the registration, evaluation, authorisation and restriction of chemical substances, much remains to be done to fully implement these frameworks. Moreover, additional regulations may be needed to address emerging risks due to new technological developments such as nanomaterials or new scientific information, e.g., on endocrine disruption or combination effects.

Over the years, Milieu has developed considerable expertise in the complex field of chemicals’ regulation. Because this requires scientific, as well as legal and policy know-how, our work in this field is carried out in close consultation with our associated senior scientists and technical experts. Our experience ranges from specialised legal and policy advice for the European Commission and other international institutions to technical assistance to governments of developing countries and countries in economic transition for establishing effective chemicals’ regulatory systems.

Some examples of Milieu’s work in this field are:

Study to support a Strategy for a Non-toxic Environment

The 7th Environment Action Programme, adopted by the European Parliament and the Council, mandates the European Commission, inter alia, to develop by 2018 “a Union strategy for a non-toxic environment that is conducive to innovation and the development of sustainable substitutes including non-chemical solutions”.

The chemicals-related objectives of the 7th EAP are not isolated but are embedded in global policy initiatives, first and foremost the goal to achieve the safe management of chemicals throughout their life-cycle.

Milieu led a consortium of three other organisations to provide expert support for the Commission’s task of developing a strategy. Specifically, the consortium pulled together reports providing the knowledge base and policy analysis for the strategy in seven specified areas:

  • Substitution, including grouping of chemicals and measures to support substitution
  • Chemicals in products (articles) and non-toxic material cycles
  • Improved protection of children and vulnerable groups from harmful chemicals’ exposure
  • Very persistent chemicals
  • Policy means, innovation and competitiveness
  • Research and development of new, non-toxic substances
  • Joint early warning systems for approaching chemical threats to health and environment

On the basis of the seven sub-studies, Milieu prepared a Final Report providing an overview and analysis of the current state of play, as well as opportunities for improvement with the aim of reducing EU citizens’ exposure to harmful chemicals. It contains some building blocks of a future non-toxic environment strategy, such as improving the knowledge on chemicals, support substitution of toxic chemicals with non or less harmful chemicals, address persistent chemicals, and establish a hierarchy for hazardous substances (avoidance, minimisation, strict controls, disposal/destruction).

The Final Report, the seven sub-study reports and the workshop report can be found on the Commission’s website.

Scientific and technical support for the Commission’s impact assessment and evaluation of the Prior Informed Consent (PIC) Regulation to ensure that hazardous chemicals banned in the European Union are not produced for export (led by Milieu), DG ENV

There are certain hazardous chemicals that are banned for use within the EU but can still be produced in the EU and exported to third countries where they can have a negative impact on human health and the environment. As part of the Chemicals for Sustainability Strategy, the European Commission is considering actions around the export of these hazardous chemicals via the PIC Regulation. In this project, Milieu is evaluating the functioning of the PIC Regulation as it stands as well as carrying out a stakeholder consultation. These will feed into the preparation of an Impact Assessment of policy options relative to the baseline.

Study on the establishment of a European Audit Capacity to ensure compliance and effective national control and enforcement of the REACH Regulation, on standards for national official control and enforcement systems for the REACH Regulation and on the extension of that capacity and of those standards to CLP (Classification, Labelling and Packaging of Substances and Mixtures), POPs (Persistent Organic Pollutants) and PIC (Prior Informed Consent) Regulations, DG ENV

As a means to reduce non-compliance, the Sustainable Chemical Strategy adopted in 2020 proposes ‘to entrust the Commission with the duty to carry out audits in Member States, where relevant, to ensure compliance and enforcement of chemicals legislation, in particular REACH, and use infringement procedures as necessary’. In this study, Milieu assisted DG ENV in identifying how to best establish a European Audit Capacity and effective control and enforcement systems for the REACH Regulation at an EU level, and in developing criteria and standards applicable to control and enforcement systems for that Regulation in Member States. The study also assessed the possible extension of the above actions for the purpose of the CLP, POPs and PIC Regulations. This study fed into the ongoing impact assessment of the REACH Regulation.