Reach as an example - results and leftovers

REACH as an example - results and leftovers

Lone Mikkelsen, Policy Officer - Chemicals The Ecological Council Aarhus, 1st March, 2013 The Ecological Council

Content • About the Danish Ecological Council?

• The role of an NGO • REACH – the chemicals legislation • What has changed?

• Limitations of REACH • What to expect from the future

Lone Mikkelsen, 1st March 2013

The Ecological Council

About us • A Danish NGO founded in 1991

• An academic organisation dealing with environmental policy on a scientific basis → trying to inform and have a dialogue with both politicians and the general public • Main subjects: agriculture, traffic, economy, chemicals, energy and climate Lone Mikkelsen, 1st March 2013

The Ecological Council

Better regulation of chemicals • 3-year project grant from the Velux Foundation

• Collaboration with Roskilde University and DTU Environment • Three key areas - Endocrine disrupting chemicals - Cocktail effects - Nanomaterials Lone Mikkelsen, 1st March 2013

The Ecological Council

Better regulation of chemicals Overall goal:

- To strengthen the NGO participation in further development of chemicals legislation in the EU • Denmark has for many years given high priority to topics related to chemical risks • Played a large role in the EU policy making Lone Mikkelsen, 1st March 2013

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The role of NGO’s • Operate independently of governmental influence • Funded mainly by private foundations → needs to follow a project description • Trying to influence legislators by stating the organizations position on specific legislation (lobbyism)

• There are believed to be about 15.000 lobbyists in Brussels Lone Mikkelsen, 1st March 2013

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Who do we lobby?

• European Commission – role in policy formulation and drafting legislation • European Parliament – accessible, the people’s representatives, key role in legislation • European Council – Policy and position tracking in Brussels, lobby at the national level • National authorities Lone Mikkelsen, 1st March 2013

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European influence Collaboration with: • European NGO’s (European Environmental Bureau) – common letters and documents • MEPs (Dan Jørgensen, Christel Schaldemose) • Danish politicians

• Danish NGO’s Lone Mikkelsen, 1st March 2013

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Main objectives of European Legislation • Harmonize regulations on chemicals of the member states ensuring the functioning of the internal market • Protect public health - originally mainly workers’ health, later general population (consumers) with increasing focus on vulnerable groups • Increasing protection of the environment - no longer only water and air pollution Lone Mikkelsen, 1st March 2013

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Paradigm shift • REACH was adopted in 2006 and entered into force in 2007 • REACH is the Regulation on Registration, Evaluation and Authorisation of Chemicals • Replaced about 40 former directives • Covers all industriel chemicals • Based on the 'polluter pays' principle Note – REACH covers ONLY industrial chemicals!

Lone Mikkelsen, 1st March 2013

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Background for legislation • Main objective: to ensure a high level of protection for human health and environment, while ensuring the efficient functioning of the internal market and stimulating innovation and competitiveness in the chemical industry • Estimation of ~100,000 chemicals on the European market • Little is known about the toxicity of about 75 % of them…

Lone Mikkelsen, 1st March 2013

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The chemicals market The level of world chemicals sales have increased threefold in 2011 compared to 10 years earlier

Lone Mikkelsen, 1st March 2013

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Environment Commissioner said…

“We have decided on a step-by-step approach to phase out and substitute the most dangerous substances – the ones that cause cancer, accumulate in our bodies and in our environment and affect our ability to reproduce. This decision is crucial for future generations"

Lone Mikkelsen, 1st March 2013

The Ecological Council

Chemicals legislation; REACH • Industry must demonstrate that they produce and use chemicals safely • Registration requirement for substances ≥1 tons per producer per year • ECHA is the driving force among regulatory authorities in the implementation of REACH

Lone Mikkelsen, 1st March 2013

The Ecological Council

REACH of today

”The research looked at 400 documents drawn up by companies… found that “most” didn´t meet the requirements…. In particular, documents lacked adequate data on the toxic effects of chemicals on reproduction…”

Lone Mikkelsen, 1st March 2013

The Ecological Council

Cornerstones of REACH • Based on the precautionary principle • SVHC on the Candidate list - 138 very hazardous substances identified so far - It is expected that 1500 SVHC may be suitable for inclusion - at this pace a comprehensive list can be expected in 2060…

• No data no market • Consumer protection - right to know (45 days) Lone Mikkelsen, 1st March 2013

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REACH timeline

Lone Mikkelsen, 1st March 2013

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Chemicals legislation; REACH • Heavy lobbyism lead to a weakening of the legal text → gaps and pitfalls • Three important groups of chemicals were even postponed to later revisions

• Endocrine disrupting chemicals • Nanomaterials

• Cocktail effects Lone Mikkelsen, 1st March 2013

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Endocrine disrupting chemicals • A compound that mimics hormones or disrupts hormone regulation • The hormon system is essential for normal development

• Effects are transferred to later generations

Lone Mikkelsen, 1st March 2013

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Nanomaterials • When materials are converted to nano-size their physical, chemical and biological properties often are fundamentally modified • Penetrates deeper into the lungs, which causes inflammation

Lone Mikkelsen, 1st March 2013

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Cocktail effects • Humans and environment are exposed to a variety of chemicals every day

• Blood from umbilical cord showed 287 chemicals (+ what was not analyzed for) ... But most legislation are based on the toxicity of single chemicals ...

Lone Mikkelsen, 1st March 2013

The Ecological Council

Why are we concerned?

Denmark has the highest reported incidence of testicular cancer • •

Semen quality low among Danish men Increasing number of boys born with malformed genitals Endocrine disrupting chemicals are suspected to be a contributing factor to these effects

Cancer Research UK; 2008 (http://info.cancerresearchuk.org)

Lone Mikkelsen, 1st March 2013

Møller, H. 1998

The Ecological Council

Potential human health effects caused by EDCs For women: Breast and reproductive organ tissue cancers, polycystic ovarian syndrome, and pelvic inflammatory diseases. Declining sex ratio (fewer women) For men: Poor semen quality (low sperm counts, high number of abnormal sperm, low number of motile sperm), testicular cancer, malformed reproductive tissue (undescended testes, small penis size), prostate disease and other recognised abnormalities of male reproductive tissues.

Other potential effects: impaired behavioral/mental, immune and thyroid function in developing children; osteoporosis, early puberty Lone Mikkelsen, 1st March 2013

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Changes following REACH • The use of chemicals in EU have become more safe since REACH BUT… more precaution is needed • Low dose effects of endocrine disrupters • Products underpinned by nanotechnology are forecast to grow from a global volume of 200 bn € in 2009 to 2 trn € by 2015 (900 % increase) • Health effects from combinations of pesticides at concentrations similar to those found in our food Lone Mikkelsen, 1st March 2013

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Danish mixture research

• New study from DTU Food with cocktail of fungicides (all EDCs) • Professor Ulla Hass (research manager): “the effects are far greater than expected, and limits should be reduced by half if you should take into account the cocktail effects” Lone Mikkelsen, 1st March 2013

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Danish mixture research • Sperm counts decreased by 62% • Lost orientation – like women • Cocktail effects at doses where the single compounds alone have no health effect

Lone Mikkelsen, 1st March 2013

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Danish greenhouse study • Pesticide cocktail among mothers • Follow up study • Premature breast development, effects on the nervous system and hypertension

Lone Mikkelsen, 1st March 2013

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Documentation for leftovers • REACH review • Late lessons from early warnings • WHO/UNEP report

Lone Mikkelsen, 1st March 2013

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REACH review

(Feb 2013)

• The Commission has concluded that REACH functions well and delivers on all objectives that at present can be assessed. Some needs for adjustments have been identified, but balanced against the interest of ensuring legislative stability and predictability, the Commission will not propose any changes to the enacting terms of REACH. Lone Mikkelsen, 1st March 2013

The Ecological Council

Our reaction • The Commission acknowledge the poor quality of the data submitted by chemical companies under REACH, but fails to propose any measures to address this through more demanding registration dossiers • Protects European industry rather than European citizens • Led to media attention Lone Mikkelsen, 1st March 2013

The Ecological Council

Late lessons from early warnings • Vol. II – published January 2013 → illustrates how damaging and costly the misuse or neglect of the precautionary principle can be, using case studies and a synthesis of the lessons to be learned and applied to maximising innovations whilst minimising harms

Lone Mikkelsen, 1st March 2013

The Ecological Council

New report from WHO/UNEP • Calls EDCs a ’’global threat’’ Three strands of evidence fuels concerns over EDCs -

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The high incidence and the increasing trends of many endocrine-related disorders in humans Observations of endocrine-related effects in wildlife populations The identification of chemicals with endocrine disrupting properties linked to disease outcomes in laboratories

Lone Mikkelsen, 1st March 2013

The Ecological Council

Expectations to the future • The EU is developing an agreed way of identifying chemicals with endocrine disrupting properties for regulatory action • Threshold for EDCs? (June 2013) • Deadline of registration for all substances >100 tons/year (May 2013)

• ”Nano patch” + clear definition • Better control with industry dossier • More focus on substitution Lone Mikkelsen, 1st March 2013

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Call-for-Action The Ecological Council calls upon the EU to: • • • • • • •

Ensure the use of the precautionary principle Base criteria on hazard and not potency Implement elimination of exposure as a goal Adopt a comprehensive def. of nanomaterials Ensure thorough evaluation of nano-dossiers Implement authorisation of nanomaterials Implement demands for mixture toxicity assessment

Lone Mikkelsen, 1st March 2013

The Ecological Council

National regulation • Possible by use of the precautionary principle Denmark as an example: -

green taxes on PVC and phthalates introduced a national ban on bisphenol A all phthalates banned in toys (0-3 year) introduced a national ban on the phthalates DEHP, DBP, DIBP and BBP - nano products register => Risk going to court with the EU Lone Mikkelsen, 1st March 2013

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Denmark as front runner

Lone Mikkelsen, 1st March 2013

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Summing up Safer use of chemicals since REACH! Much has changed for the better, but there is still much to be done!!

Very important to include EDCs, nanomaterials and mixture effects because of great health concerns Lone Mikkelsen, 1st March 2013

The Ecological Council

Thank you for your attention Find us on… our webpage: http://www.ecocouncil.dk/en/front-page Facebook (join our site: “Det Økologiske Råd”)

Twitter: ecocouncil_dk

Lone Mikkelsen, 1st March 2013

The Ecological Council