Chemical substances Harmonisation

International Conference on Harmonisation Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice, Fed Regist. Docket No. 97D-0448, 1997. 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances... 

OECD has published a document on a Harmonised integrated classification system for human health and environmental hazards of chemical substances and mixtures (OECD 2001b). Chapter 2.1 addresses a harmonized system for the classification of chemicals which cause acute toxicity, and Chapter 2.8 addresses the chemicals which cause specific target organ oriented systemic toxicity following a single exposure. 

In the OECD document Harmonised integrated classification system for human health and environmental hazards of chemical substances and mixtures (OECD 2001b), the following definitions are provided. 

International Conference on Harmonization (ICH) (1999, Oct.), Harmonised tripartite guideline Q6A, Specifications Test procedures and acceptance criteria for new drug substances and new drug products Chemical substances. 

R. D. Larsen, T. R. Verhoeven, and P. J. Reider, Mechanistic study of the Jacobsen asymmetric epoxidation of indene,/. Org. Chem. 1997, 62, 2222-2229. International Conference on Harmonisation Guidance on Q A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products, Chemical Substances. Federal Register 2000, December 29, 65(251), Notices Food and Drug Administration [Docket No. 97D-0448],... 

A major amendment was made to the Japanese Chemical Substances Control Law in April 2004 on the recommendations made by the Organization for Economic Co-operation and Development (OECD) in the Environmental Conservation Review - Further Expansion of the Regulation Scope for Conservation of Ecosystem in line with the Agenda 21 - Human Action Program for Sustainable Development of the United Nations Conference on Environment and Development (UNCED). In order to conform to international harmonisation, the amended Chemical Substances Control Law has introduced a new examination and regulation system to prevent not only hazards to human health but also damages to animals and plants. 

To some extent, public institutions may be involved in hazard and risk assessments and decide on risk management, such as for (harmonised) classification and labelling of chemical substances, for authorisation of biocides and of plant protection products and for specific regulatory activities like bans or restrictions on the use of certain very hazardous chemicals. 

OECD (Organization for Economic Co-operation and Development) (2001). OECD Series on Testing and Assessment, No. 33. Harmonised Integrated Hazard Classification System for Chemical Substances and Mixtures. Chapter 2.5. Harmonised System for the Classification of Chemicals which Cause Mutations in Germ Cells. 

The Chemicals Act requires new chemical substances to be notified by the Finnish manufacturer or importer 45 days before they are supplied in Finland. Existing non-notifiable substances are those listed in EINECS or supplied in Finland before 1 September 1990. The Finnish notification scheme closely follows the revised EC system under the Seventh Amendment Council Directive 92/32/EEC [12], but differs in certain details because it was based on the proposed Seventh Amendment not the final version. However, as from 31 October 1993 when Council Directive 92/32/EEC comes into force in the EC, the Finnish notification scheme will be amended to be fully harmonised. 

If classifying a chemical substance, the first step is to check if the substance has a harmonised classification (see Section 4.2.4). 

The Classification and Labelling Inventory is a central database of chemical substances on the EU market. The Inventory contains the classification and labelling information on substances submitted to the ECHA through REACH registrations and CLP notifications. The Inventory includes substances that have a harmonised classification. The full database is accessible to the competent authorities of the member state, but key information from the Inventory will also be made public on the ECHA website. Neither confidential business information nor the identity of companies will be disclosed to the public. 

Commission Directive 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC On the Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principles of Good Laboratory Practice and the Verification of their Applications for Tests on Chemical Substances, Official Journal L 77. 

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... 

The ISO protocol for the biochemical response EROD (ISO 23893-2/AWI) as a recent example of a bioanalytical (biomarker) [49,50] method standardised under ISO for fish needs harmonisation with the other test systems and between the laboratories (users) before implementation. Use of biomarkers (biochemical responses) in multi-arrays for environmental monitoring according to Hansen et al. [50] is complementary to chemical analysis since they can alert for the presence of ecotoxic compounds. Bringing into the WFD, the effect-related approaches concerning bioassays and biomarkers are only relevant in the context of the QN of environmental relevant substances and the good chemical status. But it is rather difficult to transfer the monitored biochemical responses or biomarkers into an operational effect-related standard. They serve as the basis for environmental protection against hazardous substances. In relation to... 

The harmonised EU safety data sheet is designed to describe systematically the hazardous properties of chemicals and to inform users about suitable and effective risk management measures. For some years this safety data sheet also has to state what (eco)toxicological standard effects have not been verified for a specific substance. The EU instrument has now been in existence for thirteen years, while the corresponding DIN predecessor had already been introduced in the 1980s. Nevertheless, many safety data sheets still indicate extensive quality shortcomings. 

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