What is REACH?
REACH is the European Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and
improve the former legislative framework on chemicals of the European Union (EU). REACH aims for increased protection of human health and the environment from the
risks that can be posed by chemicals. This Regulation places greater responsibility on all actors in the industry to manage these. A. Schulman fully supports the targets of REACH.

Pre-registration
Manufacturers and importers must pre-register substances that are already on the EU market (so-called phase-in substances), if they want to benefit from transitional arrangements that allow registering them at a later stage. Pre-registration also enables registrants to share data with other registrants and avoid carrying out redundant tests. The pre-registration period ended on 1 December 2008.

Registration
REACH requires manufacturers and importers of chemical substances (≥1 tonne/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these substances can be used safely. Each manufacturer and importer must submit a registration dossier documenting the data and the Chemical Safety Assessment to the Agency.

Legal entities outside the EU can not register a substance, except if they appoint a competent "only representative" to take up their responsibility.

Evaluation
Once the registration dossier has been received, the Agency may check that it is compliant with the Regulation and shall evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.

Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.

Authorization
Authorisation will be required for the prioritised substances of very high concern (SVHC) that are included in Annex XIV.

Companies applying for authorisation will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks.

Applicants will also have to investigate the possibility of substituting theses substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.

Restriction
The European Union can impose restrictions and prohibit or set conditions for the manufacture, placing on the market or use of certain dangerous substances or group of substances when unacceptable risks to humans or the environment have been identified.

Communication in the supply chain
Suppliers of substances must pass on information on the health, safety and environmental properties and safe use of their chemicals to their downstream users (via a Safety Data Sheet or other means). Downstream users may only use substances classified as dangerous or which are persistent, bioaccumulative and toxic (PBT and vPvB) if they apply risk management measures identified on the basis of exposure scenarios for their use.

Exemptions
This Regulation shall not apply to

• radioactive substances
• substances which are subject to customs supervision
• non-isolated intermediates
• transport of dangerous substances
• Waste
• Defence interests

Amongst others, the following substances are exempted from an obligation to register:

• Polymers but not the monomers;
• Substances of minor concern which are well defined and for which all pertaining data is available (as listed in REACH Annex IV and/or Annex V)
• Preparations i.e. formulations or mixtures where no chemical reactions are involved. However, the individual substances in such mixtures must still be registered);
• Substances in Articles provided the substances in the articles are not intentionally released under normal or reasonably foreseen conditions of use (coolant in refrigerators);
• Medicinal products/devices, food or feeding stuffs that are subject to other major bodies of legislation.

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Status on REACH

I. Pre-registration
Compounds and Masterbatches in regulatory terms are considered as preparations. A preparation has to be understood as a mixture of substances with different chemical identity.

Preparations have not to be pre-registered or registered. However, if a company manufactures or imports a preparation into the EU market they have to ensure that all components of the preparation are pre-registered or registered. Without the pre-registration or registration of single substances, further sale of the preparation is not longer allowed and possible.

Accordingly, A. Schulman/Delta Plast have taken necessary measures to ensure pre-registration and registration of such materials. The pre-registration period ended on November 30th 2008. Based upon the information received from our up-stream suppliers and the fact that for security reasons we have pre-registered a small number of substances ourselves, the availability and supply of all substances for our products has been assured. This includes also the products of the Distribution Service.

II. Registration - Supply Chain Communication
As you probably realise, we are now entering, after the pre-registration, into the next phase of the REACH legislation: the Registration of all substances within certain time-frames.

Specific duties regarding the use of additives and other components have to be fulfilled through the whole plastic supply chain, according to Article 37.2. It is therefore very important that these uses are appropriately identified, documented and their safety assessed so we can continue to use these substances in the future, to provide you the products you need from Schulman.

The Plastics Exposure Scenario Team (PEST), which represents the plastic supply chain and includes the most important associations representing additive manufacturers/importers , compounders, masterbatchers, plastics converters and plastics producers, fully supports plastics downstream users:

• to maximize the chances that their uses will be covered in the registration dossiers by reporting their uses, in line with Article 37(2) to their suppliers, before 1 December 2009,
• to confirm that their uses will be assessed.

A. Schulman/Delta Plast is actively participating in PEST and fully supports this initiative.

The limited time frame was a point of concern and therefore we have started to collect data on uses of our products ourselves. Based upon the collected info, we will determined the REACH User Descriptor codes. These user descriptor codes will be/have been forwarded to our suppliers of raw materials. We will also inform PEST about each use descriptor that they may have not covered.

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REACH Useful Links

EuPC's REACH Club:
The Club's aim is to bring together people with good knowledge of REACH and with responsibilities related to its implementation in their companies.
www.reachclub.eu

PEST - Plastics Exposure Team
This website will provide you with useful information about the identified uses in the Plastic Supply Chain.
http://pestpublic.plastics.net/

European Chemical Agency (ECHA):
http://echa.europa.eu/home_en.asp

CEFIC : European Chemical Industry Council
http://www.cefic.be/en/REACH-implementation.html

Further guidance:
http://guidance.echa.europa.eu/

Links to helpdesks of EU countries:
http://echa.europa.eu/help/nationalhelp_contact_en.asp

List of Substances of Very High Concern:
http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

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SVHC status update

Substances that are included in the Candidate List have been identified as Substances of Very High Concern (SVHC). These substances may have very serious and often irreversible effects on humans and the environment. Substances on the Candidate List may subsequently become subject to authorisation by decision of the European Commission. You can find the link to ECHA's website with the candidate list under "useful links". Since the candidate list will be regularly updated, we need to re-evaluate the presence of SVHC each time a new update is published. Please contact us for more information.

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