These are the Policy Recommendations from our “No Brainer: The impact of chemicals on children’s brain development: a cause for concern and a need for action” report, published in March 2017.
These policy recommendations are particularly focussed on the European Union’s regulatory systems for chemicals, including REACH. For full details, glossary and references see the full report. The executive summary is available here.
Recommendations for the current 5-yearly review of the EU’s main chemicals regulation, REACH
The EU is currently reviewing its main chemicals regulation REACH, and in CHEM Trust’s view there are important improvements that can be made to REACH in order to create stronger protection from chemicals with DNT properties.
- The European Chemical Agency (ECHA), the European Commission and EU Member States should work to ensure that REACH is able to assess and control groups of chemicals with DNT potential, rather than just using a substance by substance approach.
- REACH regulatory procedures, i.e. restriction and authorisation, should be considered for any industrial chemicals with evidence of DNT effects either in humans or animal studies. If there is evidence for hormone disruption (i.e. thyroid disruption) these chemicals should be identified and regulated as EDCs, with the presumption that there is no safe threshold for exposure.
- It is well known that many registration dossiers in REACH are of poor quality, and have not been updated. ECHA has suggested that there could be an implementing act clarifying the requirement to update dossiers. We would suggest that this requirement could be combined with the results of rapid screening for DNT effects in order to identify those chemicals where dossiers should be updated – and potential evaluation undertaken – due to evidence of potential DNT effects.
- A regulatory approach for cumulative risk assessment needs to be developed for REACH. A risk assessment focusing on a single substance should no longer be used to decide on safe-use for substances reported to contribute to the same adverse outcome, either because they have the same mechanism of action or mechanisms of action that converge.
1) Action on chemicals identified as having evidence of developmental neurotoxicity: using available tools to act on existing knowledge
- Given that in the case of developmental neurotoxic chemicals the brain development of future generations is at stake, it will be imperative to act on limited evidence rather than absolute proof. Final proof of causality in humans or through complete details of the mechanism of action are often impossible to achieve, and will in all likelihood require a large number of humans being harmed.
- In the assessment of the data it will be important to include results from academic studies even if they are not using internationally agreed test methods, so that a more comprehensive evidence base is used.
- All areas of chemical policy, including REACH, should develop approaches for assessing and controlling groups of chemicals with DNT potential, rather than just using a substance by substance approach.
- We call on the Commission and EU Member States to act where there is already evidence of DNT effects either in humans or animal studies, to ensure such industrial chemicals are regulated under REACH. If there is evidence for hormone disruption (i.e. thyroid disruption) these chemicals should be identified and regulated as EDCs, with the presumption that there is no safe threshold for exposure.
- Likewise, a precautionary approach to restricting pesticides and biocides with DNT properties should be adopted.
- Given the worrying research regarding DNT properties of perchlorate it should be identified as an EDC under REACH. Furthermore, a comprehensive assessment of sources is needed in order to then identify all available methods of reducing our exposure.
- In addition to the existing Commission recommendation for Member States to monitor levels of arsenic in food, the EU should also develop specific measures and advice for reducing exposures to arsenic, in particular in pregnant women and small children.
- The possibility of creating a classification system for DNT chemicals should be investigated, as already exists for carcinogens, mutagens and reproductive toxins.
2) Addressing the reality that we are all exposed to multiple chemicals all the time
- The upcoming EU Strategy for a non-toxic environment, which is due in 2018, should include a focus on measures to improve the protection of children from combined exposures to neurodevelopmental toxic chemicals.
- In its Communication on ‘The Combination effects on chemicals’, 2012, the Commission had promised a report reviewing the progress and experience associated with the actions on mixtures by the end of June 2015. However, the report has still not appeared and we recommend that it is published as soon as possible.
- The EU laws on food contact materials are very de cient, as they do not ensure EU regulation of chemicals in paper, board, ink, glues and coatings. Chemicals in food contact materials may be an important exposure route adding to the low level daily combined exposure of consumers, including children. Chemicals and chemical mixtures used for food contact materials should be adequately screened and tested for DNT properties.
- In the upcoming REACH review of 2017, the possibilities for authorities to act on known co-exposures to harmful chemicals needs to be strengthened. A risk assessment focusing on a single substance should no longer be used to decide on safe-use for substances reported to contribute to the same adverse outcome either because they have the same mechanism of action or mechanisms of action that converge. Therefore, a regulatory approach for cumulative risk assessment needs to be developed.
- EFSA has conducted some very useful work on the cumulative risk assessment of pesticides in combined assessments of those pesticides causing e ects on the nervous system and thyroid hormone system. However, to assess the overall daily exposure of a child to neurodevelopmental toxic chemicals it needs to be expanded to include chemicals from all other sources, e.g. indoor air pollution, dust and food contact materials.
3) Ensuring proper identification of chemicals with DNT properties using existing screens and tests
- Implement new and updated screens and test methods in the data requirements prescribed in EU laws, for example, including, but not limited to, those relating to industrial chemicals, pesticides and biocides, as soon as appropriate test methods become available.
- Ensure that the testing of chemicals for safety is not avoided by unjustified arguments. It should be made mandatory for all Extended One-Generation studies to include an assessment of DNT properties.
- For REACH substances which have already gone through registration, there is a need for revisiting them to see if they have the potential to cause effects on the brain development. The Commission should make it a priority to develop and fund in-silico and in-vitro screening of all those chemicals with known consumer uses. Where screening or lower-tier test data ag a concern, such chemicals should be subject
to a more in-depth substance evaluation, where further higher-tier test data can be required and assessed.
4) Development of new tests and better screens to identify chemicals that can affect all aspects of brain development and function
- A well-resourced EU Expert Task Force on Protection of the Brain should be set up with the aim of identifying and developing better screens and tests for DNT properties. One key output of this group should be the development of a rapid screening framework, which includes in-silico and in-vitro rapid screening methods so that those chemicals which need more detailed examination can be identi ed and prioritised for agreement as OECD Guideline Studies.
- A second key goal of the EU Expert Task Force, as suggested by Grandjean and Landrigan, would be to promote optimum brain health, inspiring, facilitating and co-ordinating research and public policies that protect brain health especially during the most sensitive life stages. One part of this would be to stimulate and coordinate new research to better understand brain development and function and how toxic chemicals interfere with brain development.
- There needs to be sufficient EU and national research funding for developing and improving rapid screening technologies and test methods for chemicals in use to identify those with potential to disrupt thyroid-related pathways or other potential neurodevelopmental toxicants.
- In the medium term, the test requirements in all relevant EU laws should be modi ed to include screens and tests for neurotoxicity. There is a need for a shift in emphasis from minimising the costs to industry to getting enough data to gain a reasonable assurance of safety.
- There is also a need for test methods to identify effects on brain function in old age which are due to early life exposures.
5) Better understanding of, and statistics on, neurodevelopmental disorders such as autism and ADHD
- The EU and Member States, need to improve data collection on neurodevelopmental disorders such as autism and ADHD, in order to determine more precisely any trends, over time, in brain function, both in children and in old age.
- More research is needed into neurodevelopmental disorders, focussing both on prevention and treatment.
6) Ensuring that the UK public is properly protected from hazardous chemicals
- Although the EU has not yet managed to fully address the issue of neurotoxic chemicals, it is important to note that EU regulations have already controlled a number of the chemicals of concern, and that EU laws provide a tool to address these problems.
- The UK has voted to leave the EU, which threatens to jeopardise UK public health unless the UK remains closely aligned with EU chemicals regulations.
- We would recommend that:
- a) The UK Government works to stay aligned with EU chemicals laws.
- b) The European Commission and the remaining EU27 Member States facilitate the UK’s close alignment with EU chemicals laws, in the interest of public health and the environment.
- Efforts should be made to avoid flame retardant chemicals where possible. In particular, the UK and Ireland should remove the requirement for an open flame test for furniture. The rest of EU, and recently California, require only a smoulder test, which leads to reduced use of flame retardants whilst still providing effective protection against fires.
These are the Policy Recommendations from our “No Brainer: The impact of chemicals on children’s brain development: a cause for concern and a need for action” report, published in March 2017. For full details, glossary and references see the full report. The executive summary is available here.