Safer chemicals within REACH

Beverley ThorpeClean Production Action

Oct 1, 2009

The problem that REACH addresses: unregulated chemicals

• 50,000 to 100,000 chemicals in use today

• Prior to 1981 no requirements for health and environmental impact data

• Only 5% of total chemicals in use today have full health and environmental data

• Burden of proof on regulators to show harm

• No level playing field: Innovative safer chemicals not competitive with untested older hazardous chemicals

REACH into force June 2007

Registration – Evaluation – Authorisation – Chemicals

• Any chemicals used or imported over 1 tonne or more per year per company into Europe must be registered and the supplier must now identify all risks

• Chemical producers must produce safety data sheets for 30,000 large volume chemicals

• Hazardous chemicals (substances of very high concern –SVHC) will have to be authorised if supplier wishes ongoing use in the market

• REACH replaces 40 pieces of legislation with more streamlined regulation and creates new European Chemicals Agency

http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

Scope of REACHA substance1. Used on its own2. Used in a chemical mixture (formulation); or3. Used in an article (used in another product than a chemical)

Shall not be1. Manufactured;2. Placed on the European market

(including import);1. Or used

Unless it complies with restrictions of REACH

Substances of Very High Concern

What are they?• CMR: carcinogens, mutagens,

reproductive toxins• PBT: persistent,

bioaccumulative and toxic• Substances of equivalent

concern: – Endocrine disrupting chemicals

(to be assessed in future)– Nanotechnology (to be

assessed in future)

SVHC must be authorised• Chemical producer must

register all chemicals and have them evaluated. Chemicals that fit definition of ‘substances of high concern’ must be authorised

What does this mean for products?

European Chemicals Agency More product information1. All substances that are

intended to be released in articles under normal or intended use must be registered

2. SVHC present in articles above 0.1% by weight and present above 1 tonne/yr must be notified to Agency

Manufacturers, importers, and customers must have access to information

Many downstream users supported substitution principle in REACH

Example: Water treatment industry• “To minimise priority

substances in the society and therefore also in the water cycle, it is necessary to use the product substitution principle. It should be clearly stated that where a safer alternative exists no, or time limited only, authorisation will be given.”

• European Union of National Associations of Water Suppliers and Waste Water Services (EUREAU)

Case studies: www.chemsec.org

How REACH promotes substitution of hazardous chemicals

“My goal has been achieved: all dangerous substances will be dealt with

in a way that can or will lead to substitution” – Guido Sacconi – negotiator for European

Parliament position. Dec 1, 2006

Two routes to authorisation

PBT and vP vB• No adequate control

allowed• Socio economic reasons and

availability of alternatives govern possible granting of authorisation – or not.

ALL AUTHORISATIONS ARE TIME LIMITED

CMR and P and B• an authorisation shall be

granted if the risk to human health or the environment …is adequately controlled.

• If no adequate control, “an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies.”

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How REACH promotes substitution

• Reluctance of downstream users to use authorised chemicals

• Chemical producers and users must prove safe thresholds and adequate control if they wish to continue using a chemical

• Authorisation application will be transparent and web-based allowing interested third parties to submit info on safer substitutes.

Downstream companies supported REACH

Down stream users: Right to Know

• Downstream users can now request Safety Data sheet for any authorised chemicals found in products at more than 0.1% by weight

• Consumers can then ask retailer for information; companies required to respond within 45 days

• All registered chemicals will be on publicly available database

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REACH authorisation list begins:

Seven chemicals now defined in first batch for authorisation:

1. the fragrance musk xylene2. short-chained chlorinated paraffins3. flame retardant hexabromocyclododecane (HBCDD)4. the resin hardener 4,4’-Diamino diphenyl methane

(MDA)5. and three phthalate plasticisers DEHP, BBP and DBP.

Some Timelines• June 2007 REACH becomes operational

• June 2008 European Chemicals Agency (Helsinki) becomes operational

• June 2009, 2011, 2013, 2015, 2017, 2019, 2021 Authorisation working lists published in timed batches

• Nov 2010 Registration deadline for CMRs

• June 2022 implementation finishedClean Production Action 2007

Ex: REACH and leather

• Leather has no chemicals that willbe ‘intentionally released’

• BUT: Tanners operating from the EU or for the EU need to check with their suppliers to see if SVHC listed chemicals are purchased or used in their process

• If so, and if the content is 0.1% then must comply with regulations

What needs to be done now by tanners operating from or for the European Market?

• Step 1: Ensure all chemical products being used will be registered

• Step 2: Confirm that no SVHC are present in chemicals used

• Step 3: Ensure all end uses of chemicals are defined

Thank you for listening

Beverley ThorpeInternational Director

Clean Production ActionBev@cleanproduction.org

+1 514 933 4596www.cleanproduction.org