Comparison of Regulatory Requirements for the Notification of New Chemical Substances in the European Union, the USA and Japan

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1 INSTITUTE FOR PROSPECTIVE TECHNOLOGICAL STUDIES SEVILLE W.T.C., Isla de la Cartuja, s/n, E Sevilla Comparison of Regulatory Requirements for the Notification of New Chemical Substances in the European Union, the USA and Japan EUR EN By B. Neven and R. Schubert CEBETOX, Brussels Edited by L. Bontoux IPTS European Commission - Joint Research Centre Institute for Prospective Technological Studies WTC, Isla de la Cartuja s/n E Sevilla Spain August 1998

2 Legal notice Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. The European Commission retains copyright but reproduction is authorized, except for commercial purposes, provided the source is acknowledged. Luxembourg: Office for Official Publications of the European Communities, 1998 EUR EN ECSC-EC-EAEC Bruxelles l Luxembourg, 1998 Printed in Spain

3 35()$&( The European Commission, and in particular Directorate General III (Industry), is now involved in a comprehensive reflection on the global competitiveness of the European industry. The chemical industry, as one of the major European industrial sectors, is drawing a lot of attention in this respect. IPTS is associated to this effort and is currently trying to bring light on the relationship between regulations and the innovation processes in industry. In the case of the chemical industry, the regulations controlling the notification of new chemical substances have been taken as an example to analyze the potential impact of regulations on relative competitiveness between the members of the Triad (European Union, USA, Japan). In order to get the best possible input for this task, IPTS has asked Ms B. Neven, from CEBETOX, in Brussels, an expert in the international notification of new chemical substances, to daw a comparative picture of the regulatory systems shaping the notification of new chemicals in the Triad. This picture will serve as a basis for further analyses of the factors influencing the competitiveness of the chemical industry. This report will serve IPTS in its main task of feeding into the reflections of the European policy makers, in particular because of the strong links between the regulations for the notification of new chemical substances and a fast evolving science. Beyond its strict purpose, we hope the present report will also be useful to all the people interested by the notification of new chemical substances, in particular in industry and in competent authorities. To our knowledge, no published synthesis of this international regulatory area exists to this day. L. Bontoux, IPTS August

4 TABLE OF CONTENTS Page EXECUTIVE SUMMARY 4 1. INTRODUCTION 5 2. COMPARISON OF THE NOTIFICATION PROCEDURES Notification system for new substances in the European Union Legislation Definitions Which substances have to be notified? Procedure to followed by the notifier Content of the notification dossier Procedure followed by the national authorities and by the European Commission Classification Authorities Pre-manufacture Notice for new chemical substances in the USA Legislation Definitions Which substances have to be notified? Procedure to be followed by the notifier Content of the notification dossier Procedure of the EPA Classification Authorities Notification system for new chemical substances in Japan Legislation Definitions Which substances have to be notified? Procedure to be followed by the notifier Content of the notification dossier Procedure of the Japanese authorities Classification - Chemical Designation Authorities Comparison of the notification procedures in the European Union, the USA and Japan COSTS RELATING TO THE NOTIFICATION PROCEDURE Costs of laboratory tests European Union USA Japan Costs to establish the notification dossier Fees to introduce a notification dossier European Union 25

5 3.3.2 USA Japan STATISTICS OF NOTIFICATIONS European Union USA Japan DISCUSSION AND CONCLUSION BIBLIOGRAPHY GLOSSARY ANNEXES European Council Directive 92/32/EEC EU notification requirements related to the tonnage of new substances Listing of national competent authorities in the European Union US Toxic Substances Control Act, 15 USC 2604 (TSCA 5) US Code of Federal Regulations, Title 40, Parts 720 to US EPA - New Chemicals Program US EPA Premanufacture Notice Form The Japanese Chemical Substances Control Law 147 3

6 EXECUTIVE SUMMARY In the European Union, the USA and Japan, legislation exists to control the placing on the market of new chemical substances to protect man and the environment from dangerous substances. As a consequence, in all three regions, a notification procedure is required to introduce any new chemical onto the market. This report compares these procedures. The technical information required, in accordance with the European Council Directive 92/32/EEC, contains physico-chemical, toxicological and ecotoxicological data. Depending on the amount of the substance to be placed on the European market a full or reduced dossier must be completed. A full dossier ( base set ) is required for new substances if the tonnage marketed exceeds 1 tonne per year. Under 1 tonne per year, a reduced dossier is sufficient. It must be submitted to the national competent authority in any EU Member State. The US pre-manufacture notice (PMN) can be compared to a European reduced dossier. The information to be submitted includes all the available data on chemical s identity, production volume, by-products, use, discharge into the environment, disposal practices and an estimation of human exposure. However, additional information may be requested by the authorities. The regulatory body enforcing US legislation on chemical notification - the Toxic Substances Control Act (TSCA) - is the US Environmental Protection Agency (US EPA). Notification of a new chemical substance in Japan is covered by the Chemical Substances Control Law (CSCL). This starts with ecotoxicological data concerning biodegradation and bioaccumulation, followed by a designation procedure that determines if additional data are needed. The notification dossier contains information on the chemical s identity, its physicochemical properties and ecotoxicological data regarding biodegradation and bioaccumulation. If the rate of biodegradation is low and bioaccumulation is high, long-term human toxicity tests must be conducted to obtain information on the risk to human health. The Japanese Ministry of Trade and Industry (MITI) and the Japanese Ministry of Health and Welfare (MHW) are the regulatory bodies enforcing the Japanese legislation on chemical notification. The costs related to the notification of new chemical substances arise from the required laboratory tests, the establishment of the notification dossier and its submission to the competent authority. The cost of a reduced notification dossier in the EU (Annex VII C, less than 100 kg per year) is comparable to that of a notification dossier in the USA or Japan if no supplementary information is requested. If the amount of the substance placed on the market exceeds 100 kg per year, the costs of notification in the EU will be significantly higher than in the US or Japan. Existing statistics show that the US EPA handles many more notifications than the EU or Japan. 4

7 1. INTRODUCTION In the last 20 years the regulatory requirements related to the placing of chemical substances on the market have evolved considerably throughout the world and in particular in industrialised countries. This trend has its origin in the increasing number of incidents involving chemical products on human health and the environment. The regulatory requirements are essentially aiming to provide to the public authorities adequate information regarding the hazards and the risks for the public and for the environment that chemical products may entail when placed on the market. Therefore, any manufacturer, distributor or importer which intends to place a new chemical on the market in industrialized countries is requested, in accordance with the legislation in force, to provide the public authorities with a certain amount of information on the properties of these products. This procedure is called a notification. The aim of this report is to compare the regulatory notification procedures relating to new substances which have to be implemented by the chemical industry or importers of chemical substances. This report compares the regulatory requirements in force under European Council Directive 92/32/EEC with those of the US Toxic Substances Control Act ( TSCA ) and the Japanese Chemical Substances Control Law ( CSCL ). The information requested to introduce a notification dossier to the authorities is discussed for each legislation applied in the European Union, United States and Japan. The notification procedures in force today in the EU, the USA and Japan are noticeably different in spite of the ongoing discussions at international level to achieve a global harmonisation of the regulatory requirements for new chemicals. This aspect is particularly important to avoid raising trade barriers or giving economic advantages to one or the other stakeholder. From the perspective of public interest, however, the legislative requirements regarding new chemicals are beneficial if they serve the right purpose, namely to protect human health and the environment. The economic aspects such as costs and statistics relating to notification are reported in the second part of the report. 5

8 2. COMPARISON OF THE NOTIFICATION PROCEDURES 2.1. Notification system for new substances in the European Union Legislation - Reference COUNCIL DIRECTIVE 92/32/EEC of 30 April 1992, amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (full text in annex 8.1). - Purpose of the law The purpose of the Directive is to undertake an a priori assessment of a new substance before it is marketed, thereby allowing the necessary measures to be taken to protect man and the environment from exposure to unacceptable risks. - Objective The objective of the Directive is to establish a harmonized EC-wide system of notification whereby the same procedures are applied across the Member States and wherein the information collected is exchanged between all national authorities. The Directive concerns the laws, regulations and administrative provisions of the Member States on: - the notification of substances; - the exchange of information on notified substances; - the assessment of the potential risk to man and the environment of notified substances; - the classification, packaging and labelling of substances dangerous to man or the environment. - Substances not covered by this legislation This Directive shall not apply to the following preparations in the finished state: - medicinal products for humanand veterinary use - cosmetic products - mixtures of substances in the form of waste - foodstuffs - animal feedingstuffs - pesticides - radioactive substances - substances or preparations falling under other existing Community procedures Definitions - Notification: procedure to present the documents, with the requisite information, to the competent authority of a Member State for substances manufactured within and outside the Community. - Substances: chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. 6

9 - Existing substances: EINECS: European inventory of existing commercial chemical substances Einecs is an inventory containing over entries of substances which were on the market before 18 September Einecs was published in all nine Community languages in the Official Journal of the European Communities on 15 June 1991 (OJC 146A). Each entry is accompanied by a CAS number, Einecs number and the name. Einecs is a closed inventory, this means that notified substances are not added to Einecs. ELINCS: European list of notified chemical substances. This list of new substances notified under the Directive is each year published by the Commission in the Official Journal of the European Communities Which substances have to be notified? - New substances to be notified A substance is subject to notification if: it is placed on the EC market either on its own as a substance or in a preparation; it is not in Einecs or in Elincs; it is not covered by one of the exemptions. - Exemption There are limited or no reporting requirements for new chemical substances in the following cases: additives and substances for exclusive use in animal feedingstuffs substances used exclusively as additives or as flavourings in foodstuffs active ingredients used exclusively in medicinal products for human or veterinary use substances for exclusive use in plant protection products substances placed on the EC market in quantities of less than 10 Kg per year per manufacturer polymers substances for scientific research and development substances for process-orientated research and development Procedure to followed by the notifier Notifier For substances manufactured within the EC, it is the manufacturer who must submit the notification. For substances manufactured outside the EC, there are two non-mutually exclusive options - either an importer of the substance or a person designated by the manufacturer as his sole representative. Obligation of the notifier The notification must be submitted at least 45 days before placing the substance on the market. Once the notifier has completed the notification dossier, the notification must be submitted to the national competent authority of the Member State in which the substance is manufactured, or in 7

10 the case of a manufacturer located outside the Community, the Member State within which the notifier is established. The details of the administrative procedures for the submission of dossiers vary from Member State to Member State and notifiers should contact the national competent authorities for further details. 45 days after the substance has been notified to the competent authority, the person responsible for notification is authorised to introduce the substance to the European Market. Submission of data The data for notification can be presented on a diskette according to an EC format SNIF, Structured Notification Interchange Format Content of the notification dossier A notification dossier for a new substance include essentially: - a technical dossier, including information on the notifier, identity of the substance, intended uses and the intrinsic properties of the substance (physical-chemical properties, toxicological and ecotoxicological data). With regard to the information to be provided on intrinsic properties, there are different possible testing packages to be carried out dependent upon the amounts placed on the European market (see annex 8.2). The Directive makes a difference between a Full or a Reduced notification dossier. A Full notification dossier (>1 tonne/year/manufacturer) will contain the information and test results referred to in Annex VII A ( base set ). If the amount of substance placed on the market reaches 10 tonnes or more additional test/studies are required as mentioned in Annex VIII, level 1 or level 2. For lowvolume substances (<1 tonne/year/manufacturer), a reduced notification dossier can be submitted according to Annex VII C or Annex VII B. The test procedures to be used in carrying out testing for the purpose of the notification are those set out in Annex V of the Directive. The laboratory tests carried out for notification should be conducted according to the principles of Good Laboratory Practice (GLP), which are designed to ensure that tests are carried out according to a consistently high quality standard. The requirements for GLP are set out in Council Directive 87/18/EEC. - a proposal for the classification and labelling of the substance - a proposal of safety data sheet for substances classified as dangerous, - a statement from the extra-ec producer in the case where the sole representative procedure is being employed The notification dossier may also include at the request/discretion of the notifier: - a provisional risk assessment carried out by the notifier, and, - a request to be exempted for one year from data sharing requirements Procedure followed by the national authorities and by the European Commission - The role of the national competent authorities is to: Check conformity with the Directive Inform the notifier 8

11 Respect confidentiality Classify and label Perform a risk assessment The notifier submits the dossier to the competent authority, which must then check that it meets the requirements of the Directive. The authority checks whether the information is complete, if tests have been carried out correctly and whether all the provisions in the Directive have been respected. The competent authority will then draw up a summary of the dossier. When an authority receives a notification for a dangerous substance, it submits to the Commission a proposal for the formal classification and labelling of the substance as it should eventually be introduced into Annex I of the Directive. The authorities are responsible for carrying out the risk assessment of the substance and take appropriate measures if required. - The role of the European Commission is to: Summarize of the notification dossier Classify and label List the substance in ELINCS Perform a risk assessment The summary dossier goes to the Commission, which once again checks it and immediately provides all other Member States with that summary. The information compiled is available to the competent authorities in all Member States (new substances database). The proposal for classification and labelling is communicated by the Commission to the other Member States which have six months to send comments to the originating authority. Once the final proposal is approved, the substance is introduced into Annex I of the Directive. Each year the Commission publishes the full list of notified new substances. Upon receipt of the risk assessment report the Commission circulates it to the other Member States which can comment and request changes and modifications Classification Substances are classified on the basis of their intrinsic properties according to the categories laid down in Article 2 of the Directive. The Directive recognises 15 categories of danger and detailed criteria have been elaborated for classifying substances. The general principles of the classification and labelling of substances shall be applied according to the criteria in Annex VI. Annex I contains the list of classified dangerous substances Authorities European Commission: Commission of the European Communities Directorate-General for the Environment, Nuclear Safety and Civil Protection (DG XI) 200, Rue de la Loi B-1049 Bruxelles Belgium 9

12 National competent authorities: See listing in Annex

13 2.2. Pre-manufacture Notice for new chemical substances in the USA Legislation - Reference Toxic Substances Control Act (TSCA) 5, U.S.C 2604 (see full text in Annex 8.4). The Premanufacture Notification and Review procedures are specified in an EPA final rule issued in the Federal Register on May 13, 1983, clarified on 13/09/1983 and amended on 22 /04/1986 (see Annex 8.5). The New Chemicals Program (NCP) of the US EPA Office of Pollution Prevention and Toxics (see Annex 8.6), is the program for the management of potential risk from chemicals new to commerce and is mandated by 5 of the TSCA. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by 5 of the TSCA to provide the EPA with notice before initiating the activity. - Purpose of the law The TSCA is intended to be comprehensive, and assure protection of health and the environment from unreasonable risks associated with chemicals whether the chemicals are imported or produced domestically. - Objective The premanufacture notification system establishes procedures for reporting of new chemical substances by manufacturers and importers under section 5 of TSCA. The rules defines the persons and chemical substances subject to the reporting requirements and prescribes the content of section 5 notices, and establishes procedure for submitting notices. It enables the Environmental Protection Agency (EPA) to include any new commercial chemical imported or manufactured in the Inventory of Chemical Substances. All information provided with PMN is considered by Agency risk assessors to determine whether the likely risk is unreasonable. - Substances not covered by this legislation pesticides food or food additives, drug, cosmetic nuclear material ammunitions tobacco and tobacco products Definitions TSCA is applicable to chemical substances including a chemical substance as part of a mixture or an article. - New Chemical Substances Any substance that is not on the TSCA Inventory is classified as a new chemical. - Inventory of Chemical Substances 11

14 EPA has established an inventory of existing chemical substances called the TSCA Inventory, which can be consulted from several sources such as print-out from the World Wide Web, diskettes, CD-ROM, or other commercial assistance services such as Chemical Abstract Service and Dialog. The identity of an existing chemical that has been claimed as confidential business information (CBI) will not be listed in the public portion of the TSCA inventory. If an importer or manufacturer has demonstrated in writing its intention to manufacture or import a confidential chemical substance already listed (submission of a Notice of Bona Fide Intent to Manufacture or Import inquiry), EPA will search in the confidential portion of the TSCA Inventory, and a new notification will not be required Which substances have to be notified? - New substances to be notified Any non-exempted substance not listed in the TSCA Inventory is classified as new chemical and requires a Premanufacture Notification (PMN). - Exemption There are limited or no reporting requirements for new chemical substances in the following cases: 10,000 kg or less of a substance which will be manufactured or imported each year. This is the Low Volume Exemption (LVE, revised in March 1995). the substance is manufactured or imported in small quantities for research and development and special procedural and recordkeeping requirements are met. the substance is expected to have low releases and low exposure (LoREX) and the substance is imported for test marketing and has been demonstrated to present no risk of injury to health and the environment (TME) Procedure to be followed by the notifier Notifier The notifier can be a manufacturer or an importer. Only a person incorporated, licensed or doing business in the USA may submit a notice. Obligation of the notifier Any additional information concerning reasonably ascertainable test data brought to the knowledge of the notifier during the 5 notice review period must be sent to the address shown on the 5 notice form within ten days of its receipt, but no later than 5 days before the end of the review period. In the latter case the notifier must contact EPA by telephone. This obligation concerns the following points: additional toxicology data, details on manufacture, processing, use, and disposal, likely worker exposures and environmental release and facts on innovations and improvements in product chemistry and safety practices. An importer must verify that the imported chemical substance is listed on the TSCA Inventory and, if not, comply with the provisions of the premanufacture notice. An importer must submit a premanufacture notice using EPA Form (see Annex 8.7) at least 90 days before import begins. All information submitted must be in English. 12

15 When several persons are involved in an import transaction, the notice must be submitted by the principal importer. The principal importer is the first importer who selects the new chemical substance and determines the total amount to be imported. If nobody fits the definition of principal importer in a particular transaction, the importer should contact EPA to determine who must submit the notice for that transaction. Notice of Commencement of Manufacture or Import The company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (EPA Form ) within 30 days of the date the substance is first manufactured or imported. Submission of data Information may also be submitted electronically (magnetic or other media) pursuant to an EPA published format for electronic submission (for Certification and Submitter Identification sections of Form , on paper) Content of the notification dossier Submission of data for notification of new chemical substances: Information that must be submitted on the EPA Form Part1 and Part2 (see Annex 8.7) includes all available data on chemical identity, production volume, by-products, use, environmental release, disposal practices and human exposure. All information submitted must be in English. EPA also requires with the PMN: - all existing health and environmental data in possession of the submitter, parent company or affiliates - a description of any existing data known to or reasonably ascertainable by the submitter. Importers are required to provide information only on exposure that occurs within the United States. - Polymers For polymer not covered by CFR , 49FR 46086, November 21, 1984 information on identification must be provided in accordance with CFR (see Annex 8.5). - By-products and impurities They are not subject to notification. Although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part. Submission of data from foreign countries No particular requirements for information with PMN except that reporting must be in English (not for literature references). The EPA requires to submit all data on the new substance, whether GLP compliant or not. If the data are of low quality, the EPA will discount it in the risk assessment, but the data have to be provided. 13

16 Procedure of the EPA Examination of EPA authorities Upon reception of an PMN, EPA sends to the notifier an acknowledgement letter that includes PMN number assigned to the submission and the date the PMN review began. Announcement If the agency has any concerns about the substances, the notifier is informed before the end of the review period. Otherwise the notifier will receive no subsequent information and is allowed to manufacture or import the substance the day after the review periods ends. Current status reports on notices submitted to EPA under 5 are posted to the internet home page or from TSCA hot line phone or fax Classification There is no system of classification of new chemicals based on intrinsic properties such as in the EU or on assessment of environmental or health effects such as in Japan. Additional data in compliance with the New Chemicals Programme The Programme can require submission of any additional data, including development of data through testing, when the information included with the PMN, coupled with that available to its risk reviewers from internal archives is not adequate to clarify for them whether the likely risk is unreasonable. The Instruction Manual for Premanufacture Notification of New Chemical Substances which accompanies the PMN Form upon request, explains all reporting requirements. Possible outcomes of PMN reviews Consent Orders In the case where the new chemical is not considered by EPA as being of no concern, the PMN review may lead to the negotiation of a section 5(e) consent order. This allows the PMN submitter to manufacture or import the new substance under specified conditions (e.g., use of worker protective equipment or release controls) while additional information is being developed (e.g. new test data). EPA may develop a consent order based on a finding of potential unreasonable risk or of substantial exposure. Significant New Use Rule (SNUR) Given that a consent order is not binding on other companies that may manufacture or import the substance, EPA generally promulgates a significant new use rule (SNUR) if manufacturers or importers other than the first submitter want to market the substance and/or begin other uses than those identified by the first submitter. Injunctions In the case where the agency determines that the new substance will present an unreasonable risk, Section 5(f) of the TSCA allows EPA to issue an injunction to prohibit the manufacture, processing, or distribution of the substance. New Chemical Substances added to the Inventory After receiving a Notice of Commencement of Manufacture or Import (NOC) and reviewing it, the substance is added to the Inventory and is considered as existing. Procedure to handle proprietary information 14

17 Substantiation of a confidential business information (CBI) claims is required when a Notice for Commencement of Manufacture or Import is submitted. The claim is reviewed according to some qualifying criteria Authorities U.S Environmental Protection Agency Document Control Officer Office of Pollution Prevention and Toxic Substances, M Street, SW Washington, D.C USA TEL: FAX:

18 2.3. Notification system for new chemical substances in Japan Legislation - Reference The Chemical Substances Control Law (CSCL) Nº 117- enforced on 16 October 1973, revised in 1986 to take into account OECD Minimum Premarketing Data (see Annex 8.8). - Purpose of the law The purpose of the CSCL is to prevent the contamination of the environment by chemical substances which are persistent and at the same time may be harmful to human health. The law focuses on the effects on humans through the environment. This explains the difference with the EU and the USA in testing items required. The first information to provide to the authorities are biodegradation and bioaccumulation data to estimate the risks for the environment. Thereafter the risks for humans will be evaluated. - Objective The establishement of a system of examination to determine, before the manufacture or import of a new chemical substance, whether such substances have persistence or other such properties and the implementation of the necessary regulations in the manufacture, import, use of chemical substances according to their properties. The CSCL aims also at classifying new chemical substances according to the following system: - Specified Class 1 Chemicals - Designated Chemicals - Specified Class 2 Chemicals The original list of items necessary for the notification of new chemicals was increased in order to apply this classification system. -Substances not covered by this legislation: Specified poisons (under Poisonous and Violent Substances Control Law) Stimulants (under Stimulants Control Law) Narcotics (under Narcotics and Phsychotropics Control Law) Definitions - Chemical Substances Chemical substances covered by the legislation are those deriving from a chemical reaction as elements, a compound or compounds. - Inventory of Chemical Substances (ENCS) An Inventory of chemical substances called the Japanese inventory of existing chemical substances has been published. It contains both existing and new chemicals. The new chemicals are defined as those officially notified after 20/08/1974 up up to March 26, 1991 (The Chemical Daily CO., LTD.). New confirmed chemicals are announced publicly in the Official Gazette (1 to 1.5 year after notification). - Existing chemicals 16

19 When it was put into force, the Japanese Chemical Substances Control Law was dealing only with substances being manufactured or imported at the time as existing substances. The number of registered chemicals in the Japanese inventory of existing chemicals was about in 1987, including chemicals with generic names Which substances have to be notified? - New substances to be notified Substances other than existing substances : - Chemical substances whose notification has been published by the MITI according to provisions of paragraph 3 Art. 4 of CSCL, and - Chemical substances listed in the List of Existing Chemical Substances (ENCS). Substances other than designated chemicals - Class I Specified Chemicals - Designated Chemicals - Class II Specified Chemicals - Exemptions New chemicals manufactured or imported for testing and research purposes, or reagents (used for estimation or detection) or other cases as prescribed by goverment orders are exempted of notification requirements. Other exemptions exist, with reduced test data requirements for notification for: - Low tonnage chemicals (small volume exemption): new chemicals whose use is less than 1 tonne/company/year, or 1 tonne/whole Japan/year. In this case, a notification of tonnage must be made every fiscal year. - Intermediates: possible enlargement of the application for a new chemical to intermediates. For example, exemptions can be granted for chemical intermediateseven when they are exchangedbetween more than one factory of the same company.they must be notified if the transaction occurs between two companies. - High molecular weight polymer: for polymers with a molecular weight >1000 and and less than 1% by weight of components with a MW <1000, the chemical analysis of the polymer is required instead of the standard tests Procedure to be followed by the notifier - Notifier Any person who intends to manufacture or import a new chemical substances in Japan. The notifier does not have to be the Japanese importer. The notifier can be the manufacturer or exporter from abroad. - Obligation of the notifier Notification of an imported new chemical substances must be made in advance from the exporting country. The person (from abroad) who intends to import a new chemical substance into Japan shall provide a notification dossier to the Japanese authorities (MITI and MHW) 4 months prior to begin the import of the new chemical. The data necessary for notification are submitted on a form and must include : the identification of the new chemical and some physical-chemical data the characterisation of the new chemical for designation. 17

20 The chemicals which are easily biodegradable can be manufactured or imported and need only biodegradation data. Those which are not easily biodegradable have to be tested further for bioaccumulation and possibly other toxicity tests Content of the notification dossier Submission of data for notification of new chemical substances: The following data should be filled in a form: Chemical identity Physical-chemical properties such as appearance, melting point, boiling point, relative density, water solubility, etc. Ecotoxicological data. If a substance is readily biodegradable in the test, the biodegradation test report must be submitted (including information on degradation products) and no other data are required. For poorly biodegradable substances, a bioaccumulation test or an estimation of the bioaccumulation potential based on structure analogy (e.g. QSAR) is required. If no other information is available, partition coefficient (Pow) and bioaccumulation test results must be submitted (including supporting data; hydrolytic stability as a function of ph (1st level) and dissociation constant). When Log Pow <3, a set of screening toxicity tests for long-term toxicity must be conducted and reported (28-day repeated dose toxicity using mammals, mutagenicity by means of bacterial reverse mutation assay and chromosomal aberration test using cultivated mammalian cell). When Log Pow >3 or not applicable, the bioaccumulation test data must be submitted. Even if a low bioaccumulation is concluded from the test results, the screening toxicity data must be submitted. Examination by analogy This approach is allowed for substances with a structure similar to that of certain existing chemicals with confirmed low bioaccumulation by testing or to other chemicals confirmed safe. New products formed during biodegradation If new substances formed during biodegradation are poorly biodegradable, they must be examined and data provided with the notification of the original substance. Polymers In spite of their poor solubility, polymers are usually judged as safe. Polymers satisfying a certain flow scheme can be considered as safe on the basis of data on stability, ph-change, solubility in water and organic solvents and molecular weight distribution. By-products and impurities They are neglected if they account for less than 1% by weight of the main substance. If an impurity is a Specified Class 1 Chemical, it must be notified at any concentration. Submission of data Data for a notification of a new chemical must be aquired in test facilities complying with CSCL Good Laboratory Practice (GLP) CSCL GLP applies to: biodegradation, bioaccumulation, toxicity tests including screening toxicity tests and measurement of partition coefficient. 18

21 Submission of data from foreign countries In principle OECD Test Guidelines results are accepted. Data from foreign countries must be translated into Japanese (liability of notifier engaged if error in translation). Mutagenicity tests report must follow a format and be filled out in Japanese (in official Notice issued 5/12/1986): - Form 1 for Bacterial Reverse Mutation - Form 2 for Chromosomal Aberration Test The 28-days repeated dose toxicity study test results must be notified following the specified format (Form 1 issued in Official Notice 5/12/1986) with test report translated into Japanese except for tables, figures and appendices. For test data submitted from abroad national government certification of GLP in compliance with OECD of the laboratory must be provided Procedure of the Japanese authorities Examination of authorities For a new chemical substance exported to Japan, the MITI and MHW shall determine within 4 months from the date of receipt of the notification to which category the new chemical substance belongs and inform the persons concerned of the results. If it is a manufacturer in Japan, only 3 months are required. The ministries which are notified of a new chemical decide on its designation on the basis of the notification information and according to chemical data in their possession. When a designated chemical is declared suspect, further data on health effects including toxicity test data may be required. Upon decision of final designation in Class 2 Specified Chemical, obligatory information are announced on case by case and published in the Official Gazette including tonnage, labelling requirement and technical guidelines for the prevention of environmental pollution. Control and measures taken by the authorities # For Designated Chemical Substances Public announcement of chemical s name (without delay after designation +/- after 1 to 1.5 year) Notification of the quantity of manufacture and import for every fiscal year Public announcement of the total quantity of manufacture or import if above 100 tonnes Obligatory study of hazards when deemed necessary for manufacturing or importing company in accordance with Art 24 of CSCL. The items and methods for the study are instructed in writing with the reasons for the study. Study of hazards means collection of information on long-term toxicity including literature and test results. There are no requirements to indicate the classification as Designated Chemical Substance on the container, and it remains possible to cancel the designation. # For Class 2 Specified Chemical Substances Public announcement of the name of the chemical. This occurs without delay after the designation, approximately after 1 to 1.5 year), Manufacture and import may not exceed the scheduled amount of substance manufactured, imported or imported product using the substance. This is subject to annual notification, The quantity of manufacture or import may be controlled, Notification of quantity of manufacture and import in the past 19

22 Public announcement of the technical guidelines for the prevention of environmental pollution labelling of containers #For Class 1 Specified Chemical Substances Same as above for class 2 but virtual prohibition of manufacture and import. In 1991, there were 9 substances in this list. Announcement of labelling The content of the labelling of class 2 specified chemicals is published in the Official Gazette : name, class, concentration and directions concerning safe handling and use. Announcement of Technical Guidelines for Prevention of Environmental Pollution The guidelines for the prevention of environmental pollution are also announced in the Official Gazette. Small Volume Chemicals Annual notification is required. In the case where notification of the same substance is made by several companies, the total amount of manufacture or import of that substance in Japan will be used to determine whether the quantity remains below one tonne per annum Classification - Chemical Designation Class 1 Specified Chemical Substances biodegradation low bioaccumulation high long-term toxicity risk to human health Designated 1 Chemical Substances (new since 1987) biodegradation low bioaccumulation low long-term toxicity suspicion 2 of risk to human health Class 2 Specified Chemical Substances (new since 1987) biodegradation low bioaccumulation low long-term toxicity risk to human health Authorities The authorities to which notifications must be submitted in Japan are: The Ministry of International Trade & Industries (MITI) Basic Industries Bureau 1 For designation as Designated Chemicals the situation of environmental contamination is not included in the items for examination. 2 Suspicion: because screening test are accepted. 20

23 Chemical Products Safety Division 3-1, Kasumigaseki 1-chome, Chiyoda-ku Tokyo , Japan Tel: Fax: The Ministry of Health and Welfare (MHW) Environmental Health Bureau Office of Environmental Chemical Safety Kaumigaseki, Chiyoda-ku Tokyo 100, Japan 21

24 2.4. Comparison of the notification procedures in the European Union, the USA and Japan Table 1 presents a synopsis of the legislation applicable to the notification of new chemical substances in the European Union, the United States of America and Japan. It is interesting to note that all three have a complete set of legislation aimed at protecting man and the environment from the dangers that may arise from the use of new chemical substances. All three also have an inventory of chemical substances. However, while the European system requires a standard set of data according to tonnage, the American and Japanese systems are more progressive and define their requirements as a function of the first sets of data available. While the European and Japanese systems require specific tests and the test data submitted to obey GLP requirements, this is not the case in the USA, where all available data must be submitted in the notification and there is no legal requirement to perform tests. The American is also the only one not to lead to a classification of the substances notified. While the costs of notification are generally highest in the European Union (see next chapter) due to the list of tests to be performed, the longest administrative delays for the submission of a notification dossier are to be found in Japan (up to 4 months). All three systems have an exemption of notification for small volumes of chemicals. While the limit for this exemption is set at 10 kg per year and per manufacturer in the European Union and the USA, it is much higher in Japan (1000 kg/yr.manuf.). 22

25 TABLE 1: Simplified comparison of the notification procedures for new chemical substances in the EU, the USA and Japan European Union USA Japan Name of Procedure Notification Pre-manufacture Notice Notification (PMN) Corresponding legislation and year of first publication European Council Directive 92/32/EEC (1992) Toxic Substances Control Act (TSCA) 5 (1983) Nº117 (1973) Purpose of legislation Protect man and the environment Protect man and the environment Chemical Substances Control Law (CSCL) Protect man from contamination through the environment Inventory EINECS TSCA Inventory ENCS ELINCS Info. to submit for Full technical dossier and Available data, PMN Physical-chemical and notification proposed classification & Form and physicalchemical biodegradation data PHASE 1labelling data Info. to submit for notification Safety data sheet and provisional risk Additional data, if required Additional data on bioaccumulation & longterm PHASE 2assessment toxicity if required Small volume <10 kg/year/manuf. <10 kg/year&manuf. <1000 kg/year&manuf. exemption Reduced notification Not relevant Not relevant kg/year&manuf. GLP requirement Yes No Yes Format to submit SNIF EPA PMN Form Form English/Japanese data 25 Assessment procedure - Conformity with Directive Risk and exposure assessment - Classification & labelling - Risk assessment -Assessment based on environment and health effects -Designation Classification Legal delay before import or manufacture Responsible official bodies On the basis of intrinsic properties 45 days National competent authorities and European Commission DG XI None PMN: 90 days Not. of Comm.: 30 days US EPA - Designated - Specified Class 1 - Specified Class 2 Japan: 3 months Import: 4 months MITI MHW 23

26 3. COSTS RELATING TO THE NOTIFICATION PROCEDURE 3.1. Costs of laboratory tests European Union The European Directive 92/32/EEC requires the results of laboratory tests to complete the Technical Dossier to be included in the Notification Dossier. Depending on the tonnage of the substance which will be placed on the European market a reduced or full dossier will be required (see annex 8.2). Approximate costs relating to the laboratory tests are given: Test requirements under Directive 92/32/EEC Laboratory costs (ECU) Annex VII C Annex VII B Annex VII A Annex VIII Level Annex VIII Level USA For the US PMN there is no legal obligation to conduct laboratory tests. Only available data are required. The amount of data provided is based on individual initiative of the manufacturer to obtain data and can therefore not be compared to the EU situation where laboratory tests are mandatory. However, if additional data are required by EPA, this could include laboratory tests which will be determined on a case by case basis. As a result, it is impossible to provide standard costs of tests for notification Japan In accordance with the CSCL, an Advance Report is first filed with the authorities. After review, different data requirements are defined depending on the designation of the new chemical substance. Costs related to the advanced report and to the designated level are given: Level Laboratory costs (ECU) Advance report Specified Class Designated Specified Class

27 Laboratory costs can be reduced if the information can be derived by QSAR analyses or is available in public databases Costs to establish the notification dossier Depending on the content of the notification dossier and the availabilty of the data, costs incurred by a company to establish a notification dossier can be estimated at to ECU. This evaluation is applicable to the EU, the USA and Japan Fees to introduce a notification dossier European Union The case of the European Union is complex because the practice is different in every one of the 15 Member States. It is therefore impossible to draw a general rule. The resources allocated to this study did not allow to investigate the situation in all 15 cases. As a consequence, Belgium is given here as an example. The applicable fee to file a notification dossier with the Belgian competent authorities depends on the tonnage of the substance placed on the market. The prices (1998) are the following: Annex VII C: 500 ECU Annex VII B: ECU Annex VII A: ECU For each additional test requested by the authorities, an additional fee of 500 ECU is required USA The fee for filing most PMN submissions with the US EPA is approximately ECU. Under certain conditions (small business, or intermediate substance), the fee is reduced to approximately 95 ECU ($ 100) Japan There is no fee for filing the notification dossier for a new chemical substance in Japan. 25

28 4. STATISTICS OF NOTIFICATIONS 4.1 European Union Table 2 summarizes the numbers of notifications in the European Union between 1983 and It is interesting to note that the period saw twice as many notifications as both the previous and the following three-year periods. Table 2: Statistics of notifications in the European union from 1983 to 1996 Number of submissions Total For the period the notifications are divided into 582 full notifications and 468 reduced notifications, a very balanced result. 4.2 USA Table 3 presents the statistics of notifications in the USA. The number of notifications to the US EPA reaches almost 5 times the number of notifications in the whole European Union. It is also worth noting that almost 90% of PMNs submitted to the programme complete the review process without being restricted or regulated in any way. Table 3: Statistics of notifications in the USA from 1979 to 1996 Type of submission Total Pre-manufacture notices Polymer exemptions Low volume exemptions Test market exemptions Japan Table 4 presents the statistics of notifications in Japan for the period The total number of notifications appears to be much lower than in the EU and in the USA. However, a large number of low volume exemptions appear to have been granted. Table 4: Statistics of notifications in Japan from 1987 to 1996 Number of Import notifications Number of substances Number of designated notifications declared safe substances