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 Müller – Deutscher Industrie- und Handelskammertag Public hearing on „The new REACH legislation“ European Parliament

Know-how Protection Supply chain Upstream Supplier Company Downstream user End consumer Competitor Chemical Agency Competitor outside the EU Dr. Tibor Müller 2

a. Challenges for Preparations manufacturer Formulations Level 1 Level 2 Level… Articles Chemical industry Substances … • 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. Dr. Tibor Müller 3

b. Challenges for Downstream users Submit information about the use… Producers & Down stream Importers user Intended …register use Use …or prepare a chemical safety report …do not Unintended register use Use Dr. Tibor Müller 4

Exposure categories The implementation of a simple model of exposure categories could help to protect the operational know how of downstream users. Human / Environment • Kind of exposure: oral, dermal, inhalative, environment • Exposure duration: single-/short-term, occasional/long-term • Application: private use, professional use Dr. Tibor Müller 5

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. Dr. Tibor Müller 6

Access to information for third parties Kind of information Example Remarks: • Name of substance Not confidential • Results of tox. studies • SDB (information on Article 116, 1 ingredients) • Details of full composition In exceptional cases of a preparation. (safety reasons), the Confidential Agencies may disclose the • precise use Article 116, 2 information • etc. • Request for access All other information • Declaration to request shall be accessible • Decision by the agency � Article 115 Missing legal security Dr. Tibor Müller 7

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. Dr. Tibor Müller 8

Questions? ? Dr. Tibor Müller 9