European Commission Drafts New Chemicals Legislation for Consultation

On 7 May, in a development likely to increase the number of animals tested to evaluate safety of chemicals, the European Commission published draft legislation that would “overhaul and modernize the EU's regulatory system for chemicals2.” The proposed system, which will be called “REACH” (for Registration, Evaluation, and Authorization of Chemicals), will replace 40 different existing regulations. This new legislation is intended to “increase the protection of human health and the environment from exposure to chemicals while at the same time to maintain and enhance the competitiveness and innovative capability of the EU chemicals industry2”

To minimize the need for animal testing, as well as to keep costs down, the proposal includes a system of data sharing among companies and increased flexibility of testing requirements. Non-confidential data generated by REACH will be made available through a publicly accessible database.

The Commission expects that it may take up to 11 years to phase in the system, which will include tighter controls for chemicals of highest concern (e.g., carcinogens, mutagens and reproductive toxicants). The Commission expects that ∼80% of all substances will only have to be registered, while the rest will require safety testing and subsequent authorization.

FDA to Simplify Regulations for Liquid and Free-Choice Medicated Feed

On 28 May, the Food and Drug Administration (FDA) proposed to change the regulations for liquid medicated feed and free-choice medicated feed. In doing so, it hopes to clarify the following points: “What data are required to demonstrate chemical and physical stability of a drug in liquid feed; how such data may be submitted for use in the new animal drug approval process; and which liquid medicated feeds may be manufactured in a feed manufacturing facility that has not obtained a medicated feed mill license from FDA3.” The FDA is proposing to exempt from the feed mill license requirement facilities manufacturing liquid feeds containing a Category I drug with a published formula and/or specifications. The FDA wants to ensure that regulations for free-choice medicated feed are “consistent with the requirements for liquid medicated feed, and that provisions for free-choice medicated feed and liquid medicated feed comply with the terms of the Animal Drug Availability Act (ADAA) of 1996 (ref. 3)”.