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Chemicals Beyond Control and the Need for REACH: 

Chemicals Beyond Control and the Need for REACH Y. Vicaire Toxics campaigner Istanbul - February 5th, 2005

Chemicals in the EU: 

Chemicals in the EU World’s largest chemical producer

Chemicals in the EU: 

Chemicals in the EU Current legislation: ‘existing’ v. ‘new’ substances 100,000 existing chemicals 5,000 classified as hazardous: 140(!) classified as priority substances >1,000 new chemicals/year

EU Chemicals Regulations: 

EU Chemicals Regulations Large data gaps Continued use of dangerous chemicals Inadequate risk assessments Penalises innovation

Chemicals & Toxicity Data: 

Chemicals & Toxicity Data


Availability of data on 2472 high-production volume chemicals submitted to the European Chemicals Bureau 0 10 20 30 40 50 60 70 Acute terrestrial toxicity Carcinogenicity Chronic aquatic toxicity Fertility Acute algal toxicity Biodegradation Teratogenicity Acute inhalation toxicity In vivo genotoxicity Acute fish/crustaceous toxicity Physical chemical properties Acute dermal toxicity Chronic toxicity Genotoxicity/mutagenicity Acute oral toxicity Data availability (%) Properties and Toxicities

Health & Environmental Fate: 

Health & Environmental Fate ‘The immediate concern is… that man and the environment are potentially exposed to a large number of chemical substances for which the hazardous properties have not been identified and/or risks have not been assessed.’ SEC(1998) ‘The widespread presence of small amounts of many chemicals… is causing increasing concern, because ... they may contribute to cancer, allergies, impacts on reproduction and the immune response system, and neurotoxic effects’. EEA

Health & Environmental Fate: 

Health & Environmental Fate Sources of pollution: Smokestacks and discharge pipes Wastes Consumer products Nonyphenol in pyjamas, Phthalates in PVC plastics, perfumes, shampoos Unconscious exposure to hundreds of synthetic chemicals every day Known to be capable of causing long-term diseases through direct absorption or food

Health & Environmental Fate : 

Health & Environmental Fate Widespread presence of persistent toxic chemicals in Environment and food chain Decline in wildlife populations Increasing incidence of diseases Low doses of hazardous chemicals linked with broad range of health effects

Health & Environmental Fate : 

Health & Environmental Fate The concentration of a type of brominated flame retardants in breastmilk of Swedish women doubles every five years

Health Effects in Children: 

Health Effects in Children

Health Effects in Children: 

Health Effects in Children

Health Effects in Children: 

Health Effects in Children « Cancer is the third most common cause of death among children between 1–19 years (Anderson, 2001). The incidence of child-hood cancer in the USA increased by 26% between 1975–1999. The biggest rise was estimated for brain and other nervous system cancers (50% increase) and acute lympho-cyctic leukaemia (62% increase). Only 5–10% of cancers have been linked to genetic factors, the rest are influenced by a broad range of environmental factors. »

Health Effects in Children: 

Health Effects in Children 10.000-20.000 children born each year in the Netherlands (16 mio pop.) with retardation caused by background levels of man-made chemicals* This means a doubling of retarded children in 10 years, and a halving of gifted children But also damage to their neurological, hormonal and immune systems: increased numbers of children with birth-defects, infertility, attention deficit syndrome... *Study by Medical universities of Groningen, Rotterdam, Amsterdam on health effects of Dioxins and PCBs following from pre-birth till 12 years. Funding for continuation was stopped.

UNESCO 7 May 2004 The PARIS Appeal: 

UNESCO 7 May 2004 The PARIS Appeal

UNESCO 7 May 2004 The PARIS Appeal: 

UNESCO 7 May 2004 The PARIS Appeal We, Scientists, Medical Doctors, Jurists, Ethicists and Citizens, convinced of the urgency and seriousness of the present situation, solemnly declare that : Article 1 The development of numerous current diseases is a result of the deterioration of the environment. Article 2  Chemical pollution represents a serious threat to children and to Man's survival. Article 3  As our own health, that of our children and future generations, is under threat, the Human race itself is in serious danger.

UNESCO 7 May 2004 The PARIS Appeal: 

UNESCO 7 May 2004 The PARIS Appeal #1 : ban CMRs 1 & 2 wherever possible #2 : implement precaution principle for PBTs and vPvB #3 : toxicological standards set re children’s health #4 : pesticide use reduction #5 : liability regime #7 : reinforce REACH with substitution and promote it outside EU

WHO Budapest, Hungary, 23–25 June 2004: 

WHO Budapest, Hungary, 23–25 June 2004 Fourth Ministerial Conference on Environment and Health : A FUTURE FOR OUR CHILDREN "11a. We note that large quantities of chemicals are currently produced and marketed, with largely unknown effects on human health and the environment. They constitute a potential risk for the working population as well as for the general public. Decisive action should be taken without undue delay to overcome the gaps in knowledge about the effects of chemicals on human health and to achieve sustainable development in the chemical industry. The European Union’s new chemicals policy (Registration, Evaluation and Authorisation of Chemicals – REACH) will be of vital importance to all users of such chemicals, as REACH aims to provide the information necessary for taking adequate risk management actions aimed at preventing future threats to human health and the environment. We also call upon industry to enhance the collection of relevant information for risk assessment of large-tonnage substances.”

REACH in a Nutshell: 

REACH in a Nutshell

REACH in a Nutshell: 

REACH in a Nutshell Registration, Evaluation, Authorisation of Chemicals Systematic approach to deal with chemicals Manufacturers/importers should register chemicals Member States should evaluate them Commission should authorise the use of substances of ‘very high concern’

REACH Background: 

REACH Background April 98: review EU chemicals policy Feb 01: REACH White Paper June 01: Council discusses White Paper Nov 01: EP resolution on White Paper May 03: COM draft proposal on REACH Oct 03: COM final proposal on REACH

REACH Calendar: 

REACH Calendar European Parliament Spring ‘05: Committee meetings Autumn ‘05: 1st plenary vote Spring ‘06: 2nd plenary vote Council of Ministers ‘04 - ‘05: Political agreements on different REACH Titles Autumn ‘05: Common position Autumn ‘06: EP/Council Conciliation process

REACH Main Features: 

REACH Main Features Reverse burden of proof Extend responsibility for testing and management along the entire manufacturing chain Minimize animal testing Create a knowledge base for chemicals Target the most hazardous chemicals Drive innovation


Registration The registration is the basis for the REACH system. Producers and importers of chemicals will have to provide test data and register all substances where use exceeds 1 tonne a year per producer/importer to a central database managed by a new central agency at European level. The information requirements will be proportional to production volumes and partly to the risks that the substance poses.


Evaluation National competent authorities will evaluate registration data, in particular for chemicals used in large quantities, and for example ask for data gaps to be filled. There are two types of evaluation: dossier and substance evaluation.


Authorization Chemicals of very high concern will be subject to authorization. An authorization applies to particular uses. Industry must show that a substance is or that its socio-economic value outweighs the risks before the substance is allowed to be used.


Authorization Substances of very high concern (SVHC) will be included in and subject to authorization. SVHC are defined based on their intrinsic properties and include:  CMR I + II Substances that can cause cancer, can alter genes or are toxic to the reproductive system  PBT Substances that do not break down quickly in nature (persistent) and can build up inside our bodies (bio-accumulative) and are toxic  vPvB Substances that are very persistent and bio-accumulative  Or substances of equivalent concern e.g. EDC – substances that disturb our hormone system


Restriction Substances causing unacceptable risks to human health or the environment may be restricted on an EU-wide basis through an alternative route. Restrictions are the safety net of the system. Restrictions can take the form of risk management, bans on certain uses, bans on use by consumers or a complete ban on a substance.

Assumptions of ‘Adequate Control’ thinking: 

Assumptions of ‘Adequate Control’ thinking ‘Acceptable’ levels of exposure to harmful chemicals, determined by regulators using risk assessment (current EU law) Exposure can be controlled through dilution/dispersion, but what about persistent bioaccumulative chemicals? Exposure from consumer products supposed to be negligible

Substitution Principle: 

Substitution Principle “The substitution of hazardous substances by less hazardous or preferably non-hazardous substances of technologies where such alternatives are available.”

Proposed decision-making process for authorization: 

Proposed decision-making process for authorization

Mandatory Substitution Benefits: 

Mandatory Substitution Benefits  certainty over chemicals To boost ‘green chemistry’  public confidence in the chemicals industry  industry liability  workers health and safety  human body burdens + env levels of chemicals

Substitution in existing international agreements (1): 

Substitution in existing international agreements (1) OSPAR: 15 states of North East Atlantic Region + EU: - Agreed ‘List of Chemicals for Priority Action’ (15 chemicals) to be dealt with by “the drawing up of programs and measures by 2003 for the control of discharges, emissions and losses of substances on [the Priority] list, and their substitution with less hazardous or non-hazardous substances where feasible”

Substitution in existing international agreements (2): 

Substitution in existing international agreements (2) Stockholm Convention on Persistent Organic Pollutants Directive 89/391/EEC of 12 June 1989 on measures to improve safety and health of workers Directive 2000/53/EC of 18 Sept 2000 on end-of-life vehicles Directive 2002/95/EC of 27 Jan 2003 on restriction of certain hazardous substances in electrical and electronic equipment

Examples of Substitution: 

Examples of Substitution Brominated flame retardants (BFRs) in electronics e.g. Samsung, Nokia, replaced with non-halogenated (phosphorus-based) or non-chemical alternatives e.g. metal housing instead of plastic BFRs in upholstery, furnishings e.g. IKEA, replaced with organic phosphorus PVC in plastisol-printed garments and artificial leather e.g. H&M, Marks & Spencer, replaced with other plastics PVC in toys e.g. Lego, Mattel, replaced with other plastics

A case study : PVC in garments: 

A case study : PVC in garments PVC used in plastisol-prints for children garments : - current legislation : no problem with PVC and chemical content if levels of certain chemicals remain under legal threshold (whenever they exist) - analytical findings : phthalates, alkylphenols, organotins, lead, cadmium, formaldehyde

A case study : PVC in garments: 

A case study : PVC in garments · Alkylphenols – toxic and used for textile finishing treatments and as surfactants. · Phthalates – toxic and widely used for plastisizing (softening) PVC. PVC-prints are one of the uses of phthalate-plasticised PVC that could clearly lead to long periods of direct skin contact in children, plus the potential for inhalation and even ingestion of additional quantities · Organotins – toxic and used as stabilizers in PVC. Textiles containing polymer parts, like T-shirts with prints, can contain organotin compounds such as butyl- and octyltin compounds. · Lead – toxic and used in colors and as a stabilizer in PVC. · Cadmium – toxic and used as pigment and as a stabilizer. · Formaldehyde – toxic and used for pre-shrinkage treatment and fixation of dyes & pigments. Due to its volatility, formaldehyde can be transferred readily from treated to previously untreated garments.

A case study : PVC in garments: 

A case study : PVC in garments All these chemicals will be submitted : Registration : priority as High Production Volume Chemicals (>100t) or as known PBT/CMR. Yet, PVC as a polymer will remain exempted. Evaluation : will lead to complementary findings (endocrine disrupting effects) Authorisation : as Chemicals of Very High Concern (PBT/CMR) Authorisation will most probably be refused as alternatives are available (PVC-free prints, alternative chemicals, can do without) In regard with use : pyjamas (sleep with it and sweat in it, likely to lead to exposure) and children (vulnerable population) Restriction : many of these chemicals already submitted to restrictions (phthalates in children’s toys, heavy metals) Manufacturers, brands and retailers will look forward substitution within the next 3 years after REACH adoption --> 2010 ?

Other REACH-related textile chemicals ?: 

Other REACH-related textile chemicals ? ... EDTA Brominated Flame Retardants Antimony Trioxide Teflon (PFOS chemicals) ABCs chemicals (antibacterial chemicals such as triclosan) ...

Right to Know: 

Right to Know An open and transparent chemicals regulatory system is essential to ensure a high level of protection of human health and the environment. Provision of access to information can occur through a range of methods, including: Labelling A right to know if you ask Information on the internet BUT… Information is not a substitute for regulation

Right to Know: 

Right to Know To ensure that the regulatory system can be trusted by all stakeholders To give downstream users, retailers, workers and the public the ability to make informed decisions on the substances they are exposed to or sell. To provide a market driver for safer chemicals.

Chemical Home: Key campaign tool: 

Chemical Home: Key campaign tool To raise concern on harmful chemicals in consumer products To encourage companies to commit to substitution using public leverage

More information: 

More information http://eu.greenpeace.org www.chemicalreaction.org www.chemsec.org www.panda.org/campaign/detox www.vigitox.org

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