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Downstream Users‘ Point of View Data Protection for Downstream Users
- Dr. Tibor Müller – Deutscher Industrie- und Handelskammertag
- Dr. Tibor Müller
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Downstream Users Point of View Data Protection for Downstream Users - - PowerPoint PPT Presentation
Downstream Users Point of View Data Protection for Downstream Users - - PowerPoint PPT Presentation
Downstream Users Point of View Data Protection for Downstream Users Dr. Tibor Mller Deutscher Industrie- und Handelskammertag Public hearing on The new REACH legislation European Parliament Know-how Protection Supply chain
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- Dr. Tibor Müller
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- a. Challenges for Preparations
manufacturer
Chemical industry Substances Formulations Level 1 Level 2 Level… … Articles
- Compositions of formulations are the most
protectable know-how of a preparations manufacturer.
- Only few substances in imported articles
will come under the law of REACH.
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- Dr. Tibor Müller
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- b. Challenges for Downstream
users
Producers & Down stream Importers user …register use …do not register use Intended Use Unintended Use
Submit information about the use… …or prepare a chemical safety report
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- Dr. Tibor Müller
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Exposure categories
The implementation of a simple model of exposure categories could help to protect the operational know how of downstream users.
- Kind of exposure:
- ral, dermal, inhalative, environment
- Exposure duration:
single-/short-term, occasional/long-term
- Application:
private use, professional use Human / Environment
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- Dr. Tibor Müller
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- c. Challenges for Importers
- Hugh portfolio of substances
- Effort of registration: In the majority of cases the importers of
substances will not get help from third country suppliers.
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- Dr. Tibor Müller
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Access to information for third parties
- Request for access
- Declaration to request
- Decision by the agency
All other information shall be accessible Article 115
In exceptional cases (safety reasons), the Agencies may disclose the information
- Details of full composition
- f a preparation.
- precise use
- etc.
Confidential Article 116, 2
- Name of substance
- Results of tox. studies
- SDB (information on
ingredients)
Not confidential Article 116, 1 Remarks: Example Kind of information Missing legal security
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- Dr. Tibor Müller
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Challenges and requirements
Operational know-how must be protected at all levels of the supply chain.
- The implementation of exposure categories could help to
protect the operational know how of downstream users.
- Maximum data protection in the central Chemicals Agency is a
- must. Like in the patent offices
- Access to information for third parties must be limited to the
absolute necessary minimum.
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- Dr. Tibor Müller
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