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MANUAL OF DECISIONS FOR IMPLEMENTATION OF THE SIXTH AND

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SEVENTH AMENDMENTS TO DIRECTIVE 67/548/EEC ON DANGEROUS

191

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SUBSTANCES (DIRECTIVES 79/831/EEC AND 92/32/EEC)

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Scientific Committee for Toxicity, Ecotoxicity and the Environment

2005

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CONTENTS

1 LEGAL FRAMEWORK FOR THE CLASSIFICATION, PACKAGING AND LABELLING OF

DANGEROUS SUBSTANCES, INCLUDING NOTIFICATION AND RISK ASSESSMENT. 14

1.1 INTRODUCTION 14

1.2 TITLES OF THE ANNEXES TO COUNCIL DIRECTIVE 92/32/EEC. 14

1.3 ADAPTATIONS TO TECHNICAL PROGRESS OF DIRECTIVE 67/548/EEC. 16

2 EINECS (EUROPEAN INVENTORY OF EXISTING COMMERCIAL CHEMICAL SUBSTANCES).

2.1 ESTABLISHMENT AND PUBLICATION OF EINECS 18

2.2 FOLLOW-UP TO THE PUBLICATION OF EINECS. 18

2.2.1 Notification queries relating to EINECS 18

2.2.2 EINECS corrections. 18

2.3 CRITERIA FOR REPORTING SUBSTANCES FOR EINECS . 19

2.3.1 General Remarks 19

2.3.2 Criteria 20

2.4 EINECS AND MIXTURES 24

2.4.1 Gasoline, Lubricating Oils and Lubricating Greases. 25

2.4.2 Substituted Alkyl-Benzenesulphonates. 25

2.4.3 Mixtures in EINECS - Should traces be considered as components in a substance? . 25

2.5 ISOMERS AND EINECS. 25

2.6 A DERIVATIVE OF ROSIN 25

2.7 PHOSPHATE 26

2.8 CO-ORDINATION COMPLEX. 26

2.9 COMPLEX REACTION MIXTURE OF PARTLY EINECS-LISTED, PARTLY NEW COMPONENTS

2.10 CRYSTALLINE MATRIX. 27

2.10.1 Luminescent Materials 27

2.10.2 Co-precipitate of two metals oxides (Solid solutions?) 27

2.10.3 Double salts . 27

2.10.4 EINECS entries specifying only one ionic component of a salt 27

2.11 SURFACE-TREATED METAL OXIDE POWDER 28

2.12 FATS, OILS AND EXTRACTS 28

2.13 EINECS-PROBLEMS, NOTIFICATION OF PLANT EXTRACTS 29

2.13.1 Introduction. 29

2.13.2 Principles for reporting oils, resins and other plant extracts in EINECS 29

2.13.3 Decisions on some EINECS entries concerning fats, oils and extracts 30

2.13.4 Soya bean fatty acid derivative 37

2.14 NOTIFICATION OF EXTRACTS FROM GENETICALLY-MODIFIED PLANTS 37

2.15 ROSIN/TALL OIL ROSIN . 37

2.16 PROTEIN HYDROLYSATES OBTAINED FROM OATS 38

2.17 NOTIFICATION OF A POLYGLUCURONATE 38

2.18 PETROLEUM PRODUCTS AND HYDROCARBONS IN EINECS 38

2.19 REACTION OF SUBSTANCES VERSUS PROCESSING OF PETROLEUM STREAMS. 51

3 ELINCS (EUROPEAN LIST OF NOTIFIED COMMERCIAL SUBSTANCES) 52

3.1 FOREWORD TO ELINCS 52

3.2 NOTIFICATION BY IMPORTERS/SOLE REPRESENTATIVES. 54

4 COMPETENT AUTHORITIES 55

4.1 DIRECTORY OF CONTACT ADDRESSES 55

4.2 MEETINGS OF COMPETENT AUTHORITIES . 63

5 APPLICABILITY OF THE DIRECTIVE. 64

5.1 APPLICABILITY OF THE DIRECTIVE AS REGARDS THE OBLIGATION TO NOTIFY 64

5.1.1 Notification of a natural protein isolated from a bacterium – gene-technological modification of

amino acid sequence and scope of original notification 64

5.1.2 Re-import into the EU of “out-of-spec.” material 64

5.2 MEDICINAL PRODUCTS. 65

5.2.1 Substances incorporated into pharmaceutical products 65

5.2.2 Intermediates in the synthesis of substances for incorporation in medicinal products . 65

5.3 ARTICLE 1(2): FOODSTUFFS OR FEEDINGSTUFFS – FOOD ADDITIVES AND ANIMAL FEED

ADDITIVES 65

5.4 COSMETICS 66

5.5 AROMATIC SUBSTANCES 67

5.6 POLYMERS 67

5.6.1 Single substance definition for new polymers. 67

5.6.2 2% rule for notification of new polymers 69

5.6.3 Definition of new (notifiable) polymer 71

5.6.4 Guidance document for the implementation of Annex VII D of Council Directive 67/548/EEC

(Directive 93/105/EEC) . 72

5.6.5 Specific questions concerning notification of polymers under the 6th Amendment rules 90

5.6.6 Biodegradability for RTP polymers . 90

5.6.7 No longer polymers. 90

5.6.8 Corrigendum to No -Longer Polymer List 91

5.6.8.1 No-Longer Polymers as starting material – notification requirements for the resulting product

5.6.8.2 Assignment of No Longer Polymer (NLP) status to unlisted substances. 92

5.6.9 Polymer or polycondensate? 94

5.6.10 Mixture of esters 94

5.6.11 Notification strategy using an extended family approach applied to the example of diol

polyesters 94

5.7 APPLICABILITY OF THE DIRECTIVE TO INTERMEDIATES (REDUCED TEST PACKAGE) 96

5.7.1 Protocol for the acceptance of a reduced test package for intermediates . 97

5.7.2 Implementation of Reduced Test Package for Intermediates in line with 28th ATP- outline .

guidance. 98

5.8 COMPLEX POLYSACCHARIDE GUMS, ETC…, PRODUCED BY BIOTECHNOLOGY. 108

5.9 “MIXTURES” OF ISOMERS 108

5.10 NOTIFICATION OF HYDRATED AND ANHYDROUS FORM OF THE SAME SUBSTANCE 108

5.11 DESIGNATION OF NOTIFIABLE SUBSTANCE 109

5.12 APPLICABILITY OF THE DIRECTIVE TO MICRO-ORGANISMS (NOT GENETICALLY

MODIFIED) 109

5.13 RELEASE OF NEW SUBSTANCE IN USE. 110

5.14 NOTIFICATION REQUIREMENTS OF AN ACID/BASE ‘SALT’. 110

5.15 SUBSTANCES INCORPORATED INTO AGROCHEMICAL PRODUCTS. 111

6 ARTICLES: SUBSTANCES . 112

6.1 SUBSTANCES AND PREPARATIONS MARKETED IN A SPECIFIC FORM OR WITHIN

SPECIFIC CONTAINERS. 112

6.2 FLUID FOR INSTANT PHOTOGRAPHIC FILM (ARTICLE OR SUBSTANCE?) . 113

6.3 CHEMICALLY SURFACE-TREATED SUBSTANCES 113

6.4 ARTICLE-PLASTER BANDAGES USED IN RESETTING BROKEN. 113

6.5 DYES FOR COLOUR PRINTERS. 114

6.6 POLYESTER FILM WITH NEW CHEMICALS . 114

7 NOTIFIER. 116

7.1 DEFINITION OF NOTIFIER. 116

7.2 WHO IS THE NOTIFIER? RESPONSIBILITY OF A THIRD PARTY SUBMITTING A

NOTIFICATION 116

7.3 DIRECT TRANSMISSION TO THE COMPETENT AUTHORITIES OF CONFIDENTIAL

INFORMATION BY NOTIFIERS FROM THE UNITED STATES OF AMERICA. 117

7.4 TOLL MANUFACTURING (SPECIAL PROCESSING) 117

7.4.1 Who is the notifier? . 117

7.4.2 Requirements of the 7th Amendment. 117

7.5 TWO SUBSIDIARIES IN THE EC, ONE MANUFACTURES, THE OTHER MARKETS THE

SUBSTANCE . 118

7.6 SOLE REPRESENTATIVE 118

7.6.1 The Sole Representative facility (NOTIF/13/95, as amended by NOTIF 26/2001) . 118

7.6.2 Interpretation of “any person established” . 122

7.6.3 Sole representative/importers. 122

7.6.4 Non-EU contract manufacturer 122

7.7 EXPORT AND RE-IMPORTS OF EU-MANUFACTURED SUBSTANCES 123

7.7.1 Notified substances:. 123

7.7.2 Non-notified substances:. 123

7.7.3 Designation of sole representative:. 124

8 PLACING ON THE MARKET. 125

8.1 DEFINITION OF THE TERM “PLACING ON THE MARKET” 125

8.1.1 Company division as two commercial entities: 125

8.2 EXPORT AND TRANSPORT OF SUBSTANCES HAVING REGARD TO THEIR PLACING ON

THE MARKET. 126

8.2.1 Import to EU customs territory. 126

8.3 PRE-MANUFACTURING NOTIFICATION 126

9 PROCEDURES FOR PROVISION AND EXCHANGE OF INFORMATION 127

9.1 SUMMARY NOTIFICATION DOSSIERS 127

9.1.1 SNIF files and DES software . 127

9.2 EXCHANGE OF CONFIDENTIAL INFORMATION 128

9.2.1 Courier postal delivery of confidential packages 128

9.2.2 Computer electronic management of notification annexes and follow-up correspondence . 129

9.3 SHARING OF DATA (ARTICLE 15 OF DIRECTIVE 92/32/EEC). 129

9.3.1 Data sharing - Article 15 129

9.3.2 Legal Position 129

9.3.3 Commission Proposal 130

9.3.4 Data sharing enquiries . 130

9.3.5 Procedures 131

9.3.6 Read-across between structural analogues – data sharing and confidentiality. 131

9.4 10 YEAR RULE 131

9.5 LISTING OF COMPONENTS AND IMPURITIES AND THE DEGREE OF DETAIL NORMALLY

NEEDED 132

9.6 GUIDANCE ON SPECTRAL ANALYSIS. 132

10 MULTIPLE (REPEAT) NOTIFICATION 142