EU Chemicals Legislation Topical Summary

Data Protection
January 2003

Current Requirements

Under existing EU chemicals legislation, producers and manufacturers are required to test chemicals, file a pre-market notification (if the chemical is not listed in the European Inventory of Existing Chemical Substances -- EINECS) and provisionally classify and label them into one or more categories of danger,* in accordance with the provisions of the "Dangerous Substances Directive" (Directive 67/548/EEC on the classification, labeling and packaging of dangerous substances)** and its 7th Amendment (92/32/EEC).*** The underlying criteria for the classification and labeling of a substance are laid down in Annex VI to the "Dangerous Substances Directive"; the test methods are contained in Annex V thereto.

Although the current system contains confidentiality provisions for data submitted to the authorities, it does not provide for data protection. As a result, the authorities theoretically may use data submitted by one company to the benefit of another company without compensating the data owner for such use. The applicable new EU chemicals legislation provisions -- particularly under the Registration, Evaluation, and Authorization of Chemicals (REACH) system -- likewise do not currently provide for a comprehensive and coherent data protection system that would ensure effective protection of data ownership rights. In this respect, however, discussions are still ongoing within the EU as to whether and how such a system should be included in the scope of REACH and implemented by the reviewing authorities.

Comparison with Pesticides and Biocides Data Protection Systems

EU Directive 91/414/EEC on the placing on the market of plant protection products and Directive 98/8/EEC on the placing on the market of biocidal products are valuable precedents for understanding the possible benefits and pitfalls of data protection. These directives offer two separate and complementary legal instruments for protecting active substances and product data submitted to the EU and national reviewing authorities, i.e., data protection and confidentiality. Data protection allows applicants to claim protection for certain data contained in the dossier submitted to the authorities for the review and authorization of pesticide and biocide active ingredients and products. The data packages concerned will thus be protected against possible unauthorized uses made by the reviewing authorities to the benefit of other producers who did not develop or submit data to support their registration. Accordingly, a request for data protection by an applicant, if successful, precludes other notifiers from obtaining product registrations relying on the original applicant's data, for certain time periods,**** unless the data owner expressly allows them to rely on its data, for example, through letters of access. Applicants can, however, protect their confidential business information (for example, product formulations), regardless of the potential access and/or re-use of the data by third parties.

Issues and Pitfalls with Data Protection under the Pesticides and Biocides System

• Application of data protection rules during the "transition" period.
• Distinction between "existing" and "new" data (lack of national information as to if and when data were submitted for national registrations).
• Possible conflict between the status of "new" and "existing" data during a national "data call in" during the EU review.
• Starting and expiry dates of protection ("erosion" of data protection periods).
• Data protection claims and specific data items covered.
• Bridging to studies submitted for "substantially equivalent" chemicals.
• The possibility for mandatory data sharing under national legislation (e.g., Germany).
• Minimization of vertebrate animal testing and forced data sharing ("all reasonable efforts").
• Formation of Task Forces and submission of joint data packages.
• Access to data package: obligations and duties of original notifiers vis-à-vis late notifiers.
• Parallel imports.
• Free riders (particularly in the case of biocide notifications, due to the lack of pre-existing registration systems in the Member States).
• Determination of the value of data and "fair" data compensation formula.
• The use of intellectual property rights and competition law.

Issues Currently Being Discussed under the White Paper

• The European Parliament and Council have called the Commission to present proposals on a balance between the need for transparency and business secrecy.
• Companies would have to record data concerning all their products (properties, volumes, uses, uses in products) and make those records available to the authorities if required.
• Implementation of the REACH system implies some data on testing and risk assessment shall be shared to avoid cost duplication and to minimize animal testing.
• Sharing of costs could be made on basis of market share; it is unclear how free riders and downstream users would be taken into account.
• "Meaningful and relevant information" shall be included in a public database (regulatory status, content, properties, animal tests, production volumes, use patterns, source of exposure).

These and other data protection/compensation issues will be the subject of further discussions and review within the Commission and by and among industry members. Accordingly, those companies that anticipate potentially significant impacts from the final rules on data protection and compensation must follow and, as necessary, participate in the legislative development process.

Footnotes

* These are: explosive, oxidizing, extremely flammable, highly flammable, flammable, very toxic, toxic, harmful, corrosive, irritant, sensitizing, carcinogenic, mutagenic, toxic to reproduction, and dangerous to the environment.

** Official Journal L 196 of 16 August 1967.

*** Official Journal L 154 of 5 June 1992.

**** The period of data protection for "existing" pesticide active ingredients (i.e., on the market on July 25, 1993) is five years EU-wide as of Annex I inclusion (for "new" data) and up to ten years from national authorization and in accordance with national legislation (for "existing" data); for "existing" biocide active ingredients (i.e., on the market on May 14, 2000) the protection period is ten years as of May 14, 2000 (for "existing" data) and ten years as of Annex I inclusion (for "new" data).

Last Updated: January 2003