ISO/AOAC/IUPAC International Harmonised Protocol for Proficiency Testing of (Chemical) Analytical Laboratories, Edited by M Thompson and R Wood, Pure Appl.

Participation in appropriate proficiency testing schemes which comply with the "International Harmonised Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories" (4) developed under the auspices of IUPAC/ISO/AOAC.

Laboratories participating in the monthly ring test organised by the Unione Italiana Vini (Verona, Italy) according to ISO 5725 (UNI 9225) rules and the International Protocol of Proficiency Testing for chemical analysis laboratories established by AOAC, ISO and IUPAC and ISO 43 and ILAC G13 guidelines.

Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals.

With regard to the testing of chemicals according to GLP, the relevant parts of the legislative, regulatory and administrative provisions listed below shall apply.

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex; and,

chemical products, including validation of alternative non-animal testing procedures;

The provisions of this Chapter shall apply to the testing of chemicals according to GLP, being either substances or preparations, covered by the legislative, regulatory and administrative provisions listed in section I. For the purposes of this Chapter the provisions of Article 4 of this Agreement concerning origin do not apply.

developing a coherent system based on a tiered approach, excluding chemical substances used in very low quantities, for the testing, risk assessment and risk management of new and existing substances with testing procedures that minimise the need for animal testing and develop alternative testing methods;

Participation in appropriate proficiency testing schemes which comply with the "International Harmonised Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories" (4) developed under the auspices of IUPAC/ISO/AOAC.

ISO/AOAC/IUPAC International Harmonised Protocol for Proficiency Testing of (Chemical) Analytical Laboratories, Edited by M Thompson and R Wood, Pure Appl.

The applicable laws, regulations and administrative provisions stipulating the coverage of chemicals subject to testing in accordance with the principles of GLP

AFFIRMING the need to ensure the high quality, validity and reliability of health and environmental data generated during the testing of cosmetics, industrial chemicals, pharmaceuticals, food additives, animal feed additives, pesticides (hereinafter referred to as chemicals),

The testing strategy shall be such that any mechanical effects of administration or purely physico-chemical actions of the product can be distinguished from toxicological or pharmaco-dynamic ones.

In accordance with the procedure laid down in Article 12 of this Directive, the Commission shall determine the testing methods for checking the chemical criteria and the limit values applicable.

standard concerning testing facility provided for in Article 4 of the Ordinance prescribing test items etc. relating to new chemical substances and toxicity research of designated chemical substances (Kanpogyo No 39 (1984) - Yakuhatsu No 229 (1984) - 59 Kikyoku No 85 (1984)) and amendments thereto

The Contracting Parties shall ensure the high quality, validity and reliability of safety evaluation data obtained during non-clinical testing on all chemicals as identified in Annex I before they are placed on the market.

These principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.

A biological substance is a substance that is produced by or extracted from a biological source and for which a combination of physico-chemical-biological testing and the production process and its control is needed for its characterisation and the determination of its quality.

A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control.

The species used should be selected on the basis of practical criteria, such as their ready availability throughout the year, ease of maintenance, convenience for testing, relative sensitivity to chemicals, and any economic, biological or ecological factors which have any bearing.

In accordance with the competent national authority, instructions concerning the conditions of preservation (chemical, temperature), transport, storage and time between sampling and analysis of milk shall be prepared by the testing laboratory according to the type of milk and the procedure of analysis to be used.

It is recognised that Member States will adopt GLP principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, for example the scope of initial and subsequent coverage concerning categories of chemicals and types of testing.

identification and recommendations on the priority areas for research and action including among others the potential health impacts of electromagnetic pollution sources and including particular attention to the development and validation of alternative methods to animal testing in particular in the field of chemical safety;

In addition to biological testing methods, alternative detection methods such as chemical methods and in vitro assays should be accepted if it is demonstrated that the performance of the chosen methods is not less effective than the performance of the biological method and that their implementation provides an equivalent level of public health protection.

If an exposure of five male and five female test animals to 20 mg per litre of a gas or 5 mg per litre of an aerosol or a particulate for four hours (or, where this is not possible due to the physical or chemical, including explosive, properties of the test substance, the maximum attainable concentration) produces no compound related mortality within 14 days further testing may not be considered necessary.

If an exposure of five male and five female test animals to 5 mg per litre of a gas, or aerosol of liquid or solid substance (or, where this 2s not possible due to the physical or chemical, including explosive, properties of the test substance, the maximum attainable concentration) produces, after a four-hour exposure, no compound-related mortality within 14 days, further testing may not be considered necessary.

A sequential approach to phototoxicity testing of chemicals is set out in the Appendix.

Area of expertise: Physical-Chemical testing

The Commission intends to introduce into Annex V to Directive 67/548/EEC certain alternative testing methods not entailing the use of animals, in order to make them available for the testing of chemicals according to Article 3(1) of Directive 67/548/EEC.

V. Results from the Testing of 311 Chemicals, Environ.

The provisions of this Chapter shall apply to the testing of chemicals according to GLP, being either substances or preparations, covered by the legislative, regulatory and administrative provisions listed in section I.

JIS K 00-64 Testing methods for melting point of chemical products.

CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL TESTING OF MEDICINAL PRODUCTS

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex;

Area of expertise: Physical-Chemical testing and Analytical and clinical chemistry

Whereas the main aim of any agreement concerning the mutual acceptance of data obtained during the non-clinical testing of chemicals in accordance with good laboratory practice in order to assess their safety before they are put on the market is essentially to enable trade to develop harmoniously between the parties concerned;

The validation of alternative methods for animal testing will increase in importance in support of the new testing programme of the new chemicals policy.