Preparing SMEs for REACHEnterprise Ireland, Glasnevin, 30/3/2006

QUESTIONS TO BE ANSWERED TODAY: What is REACH?

How does it effect my company?

What does my company need to do?

What is REACH? REACH stands for Registration, Evaluation and Authorisation

of CHemicals. It is a new regulation designed to manage and control the

potential hazards to human health and the environment of the manufacture and usage of chemicals within the EU.

It has important implications for the manufacturers, importers and downstream users of individual chemicals, chemicals in preparations and chemicals in “articles”.

REACH jargon explained: Manufacturer/Importer – M/I

Downstream user – (DU) a user [in the widest sense] of a chemical produced by the Manufacturer/Importer.

Competent Authority – (CA) the national body within a Member State responsible for the implementation of REACH. In Ireland, the Health and Safety Authority (HSA).

REACH Jargon continued: CMR – Carcinogenic, Mutagenic and Repro toxic. PBT – Persistent, Bioaccumulative and Toxic. vPvB – Very Persistent, very Bioaccumulative. R50-53 – Particular Risk phrases.

The above are descriptions of the effects of some chemicals. REACH defines the properties that put a chemical into one of these categories. Any chemical falling into these categories will only be available for use with Authorisation!

REACH Jargon Contd. CSR – Chemical Safety Report – required for registration of

substances manufactured in quantities >10 tonnes. A report that details the hazards associated with a particular chemical. It must contain a Chemical Safety Assessment (CSA). The CSA takes into account Risk Management Measures (RMM) put in place by the M/I or recommended by them to the DU.

ES – Exposure Scenarios – How will people and the environment be exposed to the substance? M/I and DU – two way communication required.

REACH Jargon contd. SDS – Safety Data Sheet – as per current SDS, but more

comprehensive and thorough information required. Will include information from the CSR - exposure scenarios and risk reduction measures.

RIP – REACH Implementation Project – Research projects that were “dry runs” at testing the various aspects of REACH.

The Chemicals Agency –a new EU body in Helsinki that will be responsible for the overall management of REACH.

WHY REACH There are concerns over the lack of information on the

potential hazards and risks to human health and/or the environment from the production and usage of existing and future chemicals.

Current system is inefficient.

How will REACH work? All chemicals manufactured/imported in the EU in quantities

>1 tonne must be Registered. This applies to individual substances, substances in preparations and substances in “articles”.

Registration involves the submission of a technical dossier of information on the substance to the Chemicals Agency. The details of what is required are given in the REACH Annexes.

A substance can be Registered by a consortium of companies. (Reduces costs to individual companies).

How will REACH work? Evaluation will be carried out in two steps:

Dossier evaluation – carried out by the Chemicals Agency.

Substance evaluation – carried out by the Competent Authority (in Ireland, the HSA). Overseen by the Chemicals Agency.

How will REACH work? Authorisation will be required for a company to produce or put

on the market a “substance of very high concern” – i.e. a substance that falls into any of the following categories; CMR, PBT, vPvB, or R50-53.

Authorisation will only be granted where industry shows that either (a) risks to human health and the environment are “adequately controlled” or (b) socio-economic benefits outweigh risks.

Substitution study required. Authorisation is for a fixed time.

How does REACH effect my company? If you are a M/I and you manufacture/import substances in

quantities >1 tonne, you will have to register that chemical. You can register the chemical by yourself, or as part of a

consortium. The Chemicals Agency encourages the formation of consortia via the Substance Information Exchange Forum (SIEF).

If you are a DU, you will need to supply information up the supply chain to the M/I on how you use a substance supplied by them.

How does REACH effect my company?

The cost of REACH may mean that substances with tight profit margins may no longer be produced. This will have implications for formulators.

Substitution is not always a simple, easy or cheap measure.

How does REACH effect my company? Some of the findings of a study carried out by Forfas: REACH will generate significant financial costs for chemical

manufacturers in Ireland – but costs spread over 11 years. The cost to DUs in Ireland will be significantly higher than that

estimated for the upstream manufacturing industry. The ICT hardware industry and SMEs, as predominantly

downstream users, are likely to feel the greatest impact. Due to the presence of speciality chemicals in Ireland’s

chemical industry, the potential to form consortia and share registration costs is likely to be constrained.

Key Sectoral ImpactsSummary Contribution

toSales €bn

Ireland’s Economy

Employment

Potential Impact

Chemicals 7.2 4,000 H

Chemical Importers N/A N/A M

Pharmaceuticals 28.7 21,595 M

ICT (Hardware) 19.5 36,315 H

Medical Devices 5.18 20,683 L

Food/ Drink 17.2 51,626 L

Print & Publishing 1.3 8,884 M

SMEs N/A 75,000 HH – High; M – Medium; L – Low.

N.B. Broad assessments: Every Company should assess the implications of REACH for themselves .

What does my company need to do? If you are a M/I, start gathering information together on your

chemicals. Are there gaps in the information? Do any of the substances you produce fall into any of these

categories: CMR, PBT, vPvB, R50-53? How do your downstream users use your chemicals? Do you want/need to be part of a consortium/consortia to

register your substances?

What does my company need to do? If you are a DU: Is there a danger that an essential chemical may be

withdrawn by my upstream manufacturer/importer? Does my M/I understand REACH and what it may mean for

them and their chemical product portfolio? How do I use the chemicals supplied by my M/I and do they

understand how I use it? Can I substitute a relatively low risk chemical for one of very

high concern?

REACH – Be Prepared!

Thank You for your Attention!