REACH with speaker notes

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What is REACH?

New legal requirements for hazardous substances which involve:

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Another acronym you’re likely to come across is “SIEF”

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These are set up where more than one company produces or imports a substance.All the manufacturers are expected to work together

A SIEF will be formed automatically, comprising all the relevant stakeholders foreach substance.

Once the SIEF is active, a 'Lead Registrant' can be identified. The Lead Registrant'srole is to produce the 'Lead dossier' to which the other joint registrants will refer.Joint registrants submit 'partial dossiers' containing information specific to theircompany

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Yet another acronym

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This is the regulatory agency set up to oversee REACH

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ECHA is based in Finland

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in Helsinki

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This is the responsibility of ECHA (the European Chemicals Agency) and Regulatorsand importers.

Any company manufacturing or importing into the EU a substance on its own, in apreparation (mixture of substances), or intentionally released from articles(finished manufactured goods) at or above 1 tonne per year may have to register it.This is done by submitting a dossier to the European Chemicals Agency (theAgency; ECHA), based in Helsinki.

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(i) a technical dossier, always required for all substances subject to theregistration obligations,

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(i) a technical dossier, always required for all substances subject to theregistration obligations,

(ii) a chemical safety report, required if the registrant manufactures or imports asubstance in quantities of 10 tonnes or more per year. Substances present in lowconcentrations in preparations (see Article 14(2)), and intermediates under strictlycontrolled conditions do not need a chemicals safety report.

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The REACH timeline

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This is the responsibility of ECHA (the European Chemicals Agency) and nationalRegulators.

Evaluation covers several processes under REACH. The first is simply that theAgency will assess a proportion of the substance registration dossiers it receives toensure they contain the correct information, known as ‘compliance checking’. Forsubstances registered at 100 tonnes/annum or more, any proposals for furtheranimal toxicity tests to obtain missing information to complete registration dossierswill be carefully considered by the Agency, before deciding whether to approve theproposed tests. These proposals will be particularly closely scrutinised to makesure the tests are absolutely necessary, to keep animal testing to a minimum. Thisis known as 'Dossier Evaluation'.

Finally, there is 'Substance Evaluation' in which a Member State authority will lookat all dossiers for a particular substance for which there may be a considered aneed for regulatory action. In order to ensure a harmonised approach, the Agencyshall in cooperation with the Member States develop risk-based criteria forprioritising substances for these further evaluations.

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Substances that are subject to authorisation may not be used in the EU, unless acompany (and their registered users) have been authorised to do so. This will meanthat eventually these substances are phased out of all non-essential uses.The substances that qualify for consideration for authorisation are known as‘Substances of Very High Concern’ (SVHC).

Substances to which authorisation will apply are listed in Annex XIV of REACH.

A substance on its own, in a preparation or in an article, which has been restrictedshall not be manufactured, placed on the market or used unless it complies withthe conditions of that restriction. Restriction will be used when it is felt that actionat the European level is needed.

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• Substances meeting the criteria for classification as carcinogenic, mutagenic ortoxic for reproduction (CMR) category 1 or 2 in accordance with Directive67/548/EEC;

• Substances which are persistent, bio-accumulative and toxic (PBT) in accordancewith the criteria set out in Annex XIII of the REACH Regulation;

• Substances which are very persistent and very bio-accumulative (vPvB) inaccordance with the criteria set out in Annex XIII of the REACH Regulation;

• Substances giving rise to an equivalent level of concern to substances meetingthe above criteria. Such substances may have endocrine disrupting properties orhave properties, that although not meeting the criteria for being a CMR, PBT orvPvB, there is scientific evidence of probable serious effects to human health orthe environment. Such substances will be identified on a case-by-case basis.

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• Substances meeting the criteria for classification as carcinogenic, mutagenic ortoxic for reproduction (CMR) category 1 or 2 in accordance with Directive67/548/EEC;

• Substances which are persistent, bio-accumulative and toxic (PBT) in accordancewith the criteria set out in Annex XIII of the REACH Regulation;

• Substances which are very persistent and very bio-accumulative (vPvB) inaccordance with the criteria set out in Annex XIII of the REACH Regulation;

• Substances giving rise to an equivalent level of concern to substances meetingthe above criteria. Such substances may have endocrine disrupting properties orhave properties, that although not meeting the criteria for being a CMR, PBT orvPvB, there is scientific evidence of probable serious effects to human health orthe environment. Such substances will be identified on a case-by-case basis.

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• Substances meeting the criteria for classification as carcinogenic, mutagenic ortoxic for reproduction (CMR) category 1 or 2 in accordance with Directive67/548/EEC;

• Substances which are persistent, bio-accumulative and toxic (PBT) in accordancewith the criteria set out in Annex XIII of the REACH Regulation;

• Substances which are very persistent and very bio-accumulative (vPvB) inaccordance with the criteria set out in Annex XIII of the REACH Regulation;

• Substances giving rise to an equivalent level of concern to substances meetingthe above criteria. Such substances may have endocrine disrupting properties orhave properties, that although not meeting the criteria for being a CMR, PBT orvPvB, there is scientific evidence of probable serious effects to human health orthe environment. Such substances will be identified on a case-by-case basis.

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• Substances meeting the criteria for classification as carcinogenic, mutagenic ortoxic for reproduction (CMR) category 1 or 2 in accordance with Directive67/548/EEC;

• Substances which are persistent, bio-accumulative and toxic (PBT) in accordancewith the criteria set out in Annex XIII of the REACH Regulation;

• Substances which are very persistent and very bio-accumulative (vPvB) inaccordance with the criteria set out in Annex XIII of the REACH Regulation;

• Substances giving rise to an equivalent level of concern to substances meetingthe above criteria. Such substances may have endocrine disrupting properties orhave properties, that although not meeting the criteria for being a CMR, PBT orvPvB, there is scientific evidence of probable serious effects to human health orthe environment. Such substances will be identified on a case-by-case basis.

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(a) A substance or a mixture that is classified as dangerous under Dangerous Substances Directive67/548/EEC or Dangerous Preparations Directive,1999/45/EC or classified as hazardous underthe CLP Regulation (EC) No 1272/2008; or

(b) a substance that is persistent, bioaccumulative and toxic (PBT), or very persistent and verybioaccumulative (vPvB) as defined in Annex XIII of REACH ; or

(c) a substance that included in the European Chemicals Agency’s 'Candidate List' of substances ofvery high concern (SVHC see ‘definitions section below) for reasons other than (a) and (b) givenhere.

Also if

You are a supplier and your customer requests a SDS for a mixture that is not classified asdangerous under Directive 1999/45/EC, but contains either:

(a) a substance posing human health or environmental hazards in an individual concentration of ≥1 % by weight for mixtures that are solid or liquids (i.e., non-gaseous mixtures) or ≥ 0.2 % byvolume for gaseous mixtures; or

(b) a substance that is PBT, or vPvB in an individual concentration of ≥ 0.1 % by weight for mixturesthat are solid or liquids (i.e., non-gaseous mixtures); or

(c) a substance on the 'Candidate List' of substances of very high concern (for reasons other thanthose listed above), in an individual concentration of ≥ 0.1 % by weight for non-gaseous mixtures; or

(d) a substance for which there are Europe-wide workplace exposure limits. If you are a supplier toEU countries other than the UK, then you may need to supply a SDS for substances or mixtures thatare not classified as dangerous where they have relevant national workplace exposure limit values.3. You are a supplier of a product listed as a ‘special case’ in paragraph 1.3 of Annex 1 of the CLPRegulation (EC) No 1272/2008 for which there are labelling derogations e.g. gas containersintended for propane, butane or liquefied petroleum gas.

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You do not need to provide a SDS:1. If the substances/mixtures are supplied in the UK and not classified as hazardousor considered PBT, vPvB or of equivalent concern (e.g. endocrine disruptors).

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You do not need to provide a SDS:

2. For certain products intended for the final user, e.g. medicinal products orcosmetics.

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You do not need to provide a SDS:

2. For certain products intended for the final user, e.g. medicinal products orcosmetics.

You do not need to provide a SDS:

3. If you offer or sell dangerous substances or mixtures to the general public andyou provide sufficient information to enable users to take the necessary measuresas regards safety and the protection of human health and the environment.However, a downstream user or distributor can ask you to provide one.containers intended for propane, butane or liquefied petroleum gas.

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You do not need to provide a SDS:1. If the substances/mixtures are supplied in the UK and not classified as hazardousor considered PBT, vPvB or of equivalent concern (e.g. endocrine disruptors).2. For certain products intended for the final user, e.g. medicinal products orcosmetics.3. If you offer or sell dangerous substances or mixtures to the general public andyou provide sufficient information to enable users to take the necessary measuresas regards safety and the protection of human health and the environment.However, a downstream user or distributor can ask you to provide one.containers intended for propane, butane or liquefied petroleum gas.

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Other changes are being introduced to CHIP too. The old, familiar labels are goingto change

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This is the CLP timeline

The new labels will be mandatory for substances from 2011

Notice the different requirements for mixtures. They can have the old style labelsuntil 2015 – could be confusing!

(note DSD was implemented in the UK as CHIP)

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This is the CLP timeline with the REACH timeline superimposed

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These are the labels we’re used to

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This is what the new labels will look like

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REACH OTS, Norwich 21 March 2007

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New pictograms are being introduced

As well as changes to the pictograms:

R and S phrases are being replaced by new “hazard statements” and“precautionary statements”

The familiar hazard classifications (“Harmful”, “Toxic”, “Highly flammable” etc) willbe replaced by new “signal words” –”Warning” or “Danger”

Picture source:http://www.merck-chemicals.co.uk/ghs-fakten-and-termine/c_aUyb.s1OYBwAAAEdocAMDpwr;sid=SPMEnMQzl8QAnIj2I8IWy2zzm_CBgwwnj9w6u2vybcPpbdQvSyr5pO00aQcd2K3aXb_5pO00m_CBgxcwzew6u2vy?back=true

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Detailed guidance on all aspects of REACH and the CLP are available on the ECHAwebsite http://guidance.echa.europa.eu/guidance_en.htm

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Source: ECHA

Looks a bit complex! Lets try and simplify it a little

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For the technical dossier, registrants should collect all the relevant informationavailable already. This information should then be compared against theinformation requirements outlined in Annexes VI to X of REACH, which specify theinformation required for the different tonnage bands.

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All uses need to be identified, including the manufacturer’s own use, and uses byall uses by downstream users.

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Exposures will need to be characterised

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These should be included in the extended safety data sheet and passed on todownstream users

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A downstream user is a company (or a professional) who uses a chemicalsubstance on its own or in a preparation in his industrial or professional activity.

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If his use is not covered by an exposure scenario, or the advice is not appropriate,the downstream user should contact his supplier in order to get his use covered inthe exposure scenario. Alternatively, he may need to develop his own chemicalsafety report.

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A downstream user is obliged to inform his supplier if he has new information onthe hazard of the substance or preparation, or if he believes that the riskmanagement advice provided is not appropriate.

Formulators must supply their customers with information on hazards and safeconditions of use for their substance (including risk management measures).Formulators are required to forward exposure scenario information received fromtheir suppliers to their own customers.

A downstream user producing articles containing more than 0.1% (w/w) of asubstance of very high concern (SVHC) must provide his customers with sufficientinformation to enable safe use of the articles and at least the name of the SVHC. Alist of such substances which are candidates for an authorisation procedure will beavailable on the Agency’s website. The first publication is expected early 2009.

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REACH is about minimising the risks from chemicals to users and to theenvironment.

It is already having a major impact on the chemical industry who are having toregister their products.

Many downstream users still aren’t aware of the implications that REACH will havefor their use and control of chemicals.

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