~dREACH Update

~tCEFIC publishes model SIEF data-sharing agreement

~w2009-10-27

The European Chemical Industry Council (CEFIC) has made available a free model agreement on data sharing within substance information exchange fora (SIEFs) drawn up by its team of in-house and company lawyers.The agreement is based on on the assumption that the lead registrant or appointed external service provider for a SIEF will enter into a bilateral data licensing agreement with data owners and then sub-licence these rights to other SIEF members via the SIEF agreement. In an explanatory note, CEFIC advises that it would be most practical to calculate data compensation costs based on a "best possible estimate" of likely numbers of SIEF members. Under the agreement, the following issues are covered:

definitions eg. "affiliates", exactly which rights are granted by the agreement eg. for REACH purposes only,

data ownership;

financial compensation, including complexities such as tax liabilities;

changes of legal entity;

liabilities;

dispute resolution.

A model letter of access is annexed to the agreement. In addition, CEFIC has published a diagram to show how its several model agreements may be used with one another. For a copy of the agreement go to:

Details of the agreement can be found in the explanatory notes: note_05.10.09.doc

Chemical Watch, 6 October 2009

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~dREACH Update

~tREACH –Substance Identity Workshop

~w2009-10-27

The European Chemicals Agency (ECHA) has announced that on the 1st December 2009, it will hold a SubstanceIdentity Workshop in Helsinki.The workshop will clarify key substance identity concepts in the context of REACH processessuch as inquiry and registration. This workshop is aimed at people in companies who are responsible for dossier preparation who havequestions regarding substance identity. Since the number of places available is limited to 100,companies are invited to send one delegate only. Participation will then be confirmed on afirst come first served basis.The morning session will include presentations on the following topics:

• Substance identity concepts;

• Introduction to the inquiry process and dossier preparation;

• Common substance identity issues.

The afternoon session will give the opportunity to discuss specific substance identity relatedquestions with members of ECHA’s substance identity team on a one to one basis. For details of the agenda go to:

ECHA, 16 October 2009

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~dREACH Update

~tGuidance in a nutshell

~w2009-10-27

The European Chemicals Agency (ECHA) is producing a series of shortened versions of the REACH Guidance Documents with the aim of making the corresponding Guidance Documents published by the Agency more accessible for industry.These documents explain in simple terms the main elements of the full guidance to industry managers including managers of small and medium sized enterprises. It will enable companies to have a quick overview of the implications for them of different aspects of REACH. Such shortened documents providing guidance in a nutshell cannot contain all details and therefore, it is advised to consult the full guidance in case of any doubt.Some of these documents have been or will be translated into 21 official EU languages. You can access the translations from this webpage: use the language menu on the top right corner of the page.

Guidance in a nutshell on requirements for substances in articles
Guidance in a nutshell:

Relevant guidance:

Fact sheet:

Guidance in a nutshell on registration data and dossier handling
Guidance in a nutshell
Relevant guidance:

Fact sheet

ECHA, 19 October 2009

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~dREACH Update

~tChemSec and other NGOs concerned about public access to information

~w2009-10-27

ChemSec and six other public interest organisations are concerned about the way ECHA envisions dealing with public access to information on chemical substances, such as the dissemination of registration data to the public. It would seem that ECHA is leaning towards keeping data confidential than providing access to information. ECHA’s preliminary setting for data falling under Article 119.2 is confidentiality, whereas the legal text says information shall be published unless a confidentiality claim has been submitted that has been “accepted as valid by the Agency”. In the view of ChemSec, the Aarhus Regulation 1367/2006 needs to be fully considered, in particular that, beyond ensuring access to information via individual requests, it also provides for an active information policy. Furthermore, concerns remain that ECHA has not yet developed a policy on how to decide on accepting or rejecting the justifications for confidentiality claims. Instead, several issues discussed in the ECHA documents seem to be treated as simple IT or technical issues, although they imply crucial interpretations of the REACH text and should be discussed, and criteria be set at the policy level. A careful balance of public and industry interests is needed in the considerations of the benefits of disclosure. ChemSec, together with the European Consumer’s Organisation, Friends of the Earth Germany, CHEM Trust, the European Environmental Bureau, the Health and Environment Alliance and WWF, ask the delegations at the CARACAL meeting to take note of their concerns;

  • “The Public” is more than the average consumer
  • Other EU laws on access to information must be considered
  • Clear procedures and objective criteria on deciding confidentiality claims are required
  • Contextual information for data is necessary

To date, ECHA has not yet made the non–confidential information of already submitted registration dossiers publicly available on the Internet and it is urged to fulfil their respective obligations as soon as possible.MemberState delegations have been called upon to ensure Aarhus requirements are incorporated into all access to information policy and that ECHA develops a considered and balanced information policy.

ChemSec, 15 October 2009

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