Reach as an example - results and leftovers

The Ecological Council

REACH as an example - results and leftovers

Lone Mikkelsen, Policy Officer - Chemicals


Aarhus, 1st March, 2013

Content

The Ecological Council Lone Mikkelsen, 1st March 2013

• 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

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

• 3-year project grant from the Velux

Foundation

• Collaboration with Roskilde

University and DTU Environment

• Three key areas

- Endocrine disrupting chemicals

- Cocktail effects

- Nanomaterials

Better regulation of chemicals



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


• 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

The role of NGO’s


• 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

Who do we lobby?


Collaboration with:

• European NGO’s (European

Environmental Bureau) – common

letters and documents

• MEPs (Dan Jørgensen, Christel

Schaldemose)

• Danish politicians

• Danish NGO’s


European influence


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


• 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!


Paradigm shift

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…


The chemicals market

The level of world chemicals sales

have increased threefold in 2011

compared to 10 years earlier


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"



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


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…”


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)


REACH timeline


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

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


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


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 ...


Why are we concerned?

Cancer Research UK; 2008

(http://info.cancerresearchuk.org) Møller, H. 1998

• 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

Denmark has the highest reported incidence

of testicular cancer

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


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 The Ecological Council Lone Mikkelsen, 1st March 2013

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”


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


Danish greenhouse study

• Pesticide cocktail among mothers

• Follow up study

• Premature breast development, effects

on the nervous system and hypertension


Documentation for

leftovers

• REACH review

• Late lessons from early warnings

• WHO/UNEP report


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.


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


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


New report from WHO/UNEP


• Calls EDCs a ’’global threat’’

Three strands of evidence fuels

concerns over EDCs

- 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

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

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

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 The Ecological Council Lone Mikkelsen, 1st March 2013

Denmark as front runner


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

Find us on…

our webpage:

http://www.ecocouncil.dk/en/front-page

Facebook (join our site: “Det Økologiske Råd”)

Twitter: ecocouncil_dk


Thank you for your

attention





Reach as an example - results and leftovers

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