Endocrine Disrupting Chemicals. - according to REACH regulation

Transcription

1 Endocrine Disrupting Chemicals - according to REACH regulation Lone Mikkelsen Policy officer Chemicals Copenhagen Chemicals Summit 29/9 2016

2 Agenda Absence of adequate regulation for endocrine disrupting chemicals (EDCs) EU-proposal on criteria for EDCs (EU biocides and pesticides legislation) - are they functional and science-based? - are they fulfilling their aim to protect human health and the environment? Pros and cons - are the criteria suitable to cover more regulations, like REACH?

3 Why are we concerned? Strong scientific proof from animal studies Many indications that the same health effects are seen in humans Chemicals are evaluated at single substance level -> cocktail effects are underestimated

4 EU-Commission health effects Human studies A number of observations of adverse effects have been made in which endocrine disruptors could play a role, including: Declining sperm counts: Some studies in certain western countries have reported decreases in sperm numbers over the last 50 years. However, other studies in different regions have failed to detect such changes. Congenital malformations in children: In recent years there has been an increase in the incidence of hypospadias (a congenital abnormality of the urethra in the penis) and cryptorchidism (undescended testes) in humans. However, no causal association with chemical exposure has yet been established. Cancer: Increased incidences of hormone-related cancers of both women (breast & ovary) and males (testes & prostate) have been observed in the West and in countries adopting Western lifestyles. Again a causal association with chemicals has not been shown, and numerous other lifestyle factors are known to be important. Retarded sexual development: A few reports have been published suggesting that adolescents in polluted areas may take longer to reach puberty. However, the potential mode of action of any such effect is unknown. Retarded neurobehavioural development: Studies in Denmark and USA have suggested that children born in polluted areas have some impairment of memory and intelligence.

5 Adequate regulation REACH entered into force in June 2007 Art 138.7: Insufficient knowledge but recognition of the problem with EDCs Partial legislation like toys and childcare articles We are still highly exposed

6 EDCs in children's rooms EDCs in dust phthalates and phosphorous-based flame retardants Try to protect children through legislation on children's articles It does not work sufficiently We found harmful chemicals in all children s rooms

7 Phthalates Phthalate concentration (ug/g) We found DEHP in all rooms -> and by far the highest levels Danish Consumer Council: 3 out of 9 school bags contained phthalates

8 Flame retardants PFR concentration (ng/g) We found 8 flame retardants in all rooms -> 2 out of 3 carcinogenic flame retardants in high levels Danish Consumer Council: More children safety seats contained flame retardants (high TCPPconc.)

9 Concern, but no action After our press release: Danish EPA: Denmark works for an EU-ban on harmful flame retardants Our results show: Despite ban in articles for children, they are still exposed to EDCs (e.g. through dust) We are not concerned about the single exposure, but the contribution to the overall exposure

10 Legislation works! We are not protected Phthalate concentration (2008 vs. 2015) Phthalate ban in toys and childcare articles since 1999 (DK) and 2006 (EU) Pregnant women are less exposed to endocrine disruptors (Feb 2016) We need clear criteria to measure all EDCs

11 EDC criteria (biocides/pesticides) Proposed by EU-Commission June 2016 Overall, it will weaken the level of protection -> fewer EDCs will be identified - may cause adverse effects -> known to cause - More extensive requirements for documentation of effects on humans and animals - No opportunity to use QSAR - Increased requirements for test protocols (OECD)

12 How to make strong criteria The criteria must: - increase the level of protection - be logical and consistent with other EU legislation - exclude potency in the identification Documentation for adverse effects should be consistent with that of CMR substances

13 Horizontal EDC criteria? Today, EDCs are identified case-by-case in REACH -> Candidate list Proposed criteria are not logical, operational and manageable neither for scientists nor industry Industry has responsibility to use chemicals safely

14 While we are waiting We call for common EU-legislation National initiatives and alliances can speed up EU process Help industry with tools to (easy) substitution Give consumers tools to avoid EDCs if they wish to -> greater trust in products Industry/NGO alliances help to identify common wishes to legislation

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