ENJEUX SANITAIRES ET RÉGLEMENTAIRES : FAUX PROBLÈMES ET VRAIES QUESTIONS. Françoise AUDEBERT Aurore BOUDET MOUFAREK 9 avril 2013
|
|
- Sibyl Simmons
- 8 years ago
- Views:
Transcription
1 ENJEUX SANITAIRES ET RÉGLEMENTAIRES : FAUX PROBLÈMES ET VRAIES QUESTIONS Françoise AUDEBERT Aurore BOUDET MOUFAREK 9 avril 2013
2 PERFUME & REGULATORY ISSUES IN EUROPE 1. Definition Fragrance ingredient Fragrance compound Perfume 2. Regulatory requirements Fragrance compound Perfume 3. Fragrance allergens SCCS opinion 2
3 Definition fragrance ingredient By definition a fragrance ingredient is a substance. Regulation (EC) N 1223/ Article 2 substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability 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 3
4 Definition fragrance compound By definition a fragrance compound is a mixture a mix of fragrance ingredients that will enter composition of a perfume. Regulation (EC) N 1223/ Article 2 mixture means a mixture or solution composed of two or more substances. For example: Fine fragrance perfume for women contains around 20% of fragrance compound Shower gel contains around 1% of fragrance compound Body cream contains around 0.5% of fragrance compound 4
5 Definition perfume By definition a perfume as a finished product is a cosmetic product. Regulation (EC) N 1223/ Article 2 cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours 5
6 fragrance compound By definition a fragrance compound is a mixture a mix of fragrance ingredients that will enter composition of a perfume. As part of a perfume (cosmetic product) a fragrance compound should conform: à REACH/CLP à Regulation (EC) N 1223/2009 (cosmetic regulation) à IFRA Code of Practice à Client s brief and requirements 6
7 fragrance compound à REACH /CLP As substances and mixtures perfume ingredients must comply to: Regulation (EC) n 1907/2006: REACH Regulation (EC) n 1272/2008: CLP Ingredients classified as CMR by Regulation CLP are now automatically forbidden They shall only be used with a positive opinion of the SCCS IFRA has updated its transparency list, which lists ingredients that may be contained in fragrance compounds. 7
8 fragrance compound à Regulation (EC) N 1223/2009 (cosmetic regulation) Annexes of cosmetic regulation Annex III List of substances which cosmetic products must not contain except subject to the restrictions laid down Example : 8
9 fragrance compound à Regulation (EC) N 1223/2009 (cosmetic regulation) Annexes of cosmetic regulation Annex V List of preservatives allowed in cosmetic products Example: à Perfume ingredients in Cosmetic Regulation annexes can be: limited in concentration labelled on finished product (26 allergens only) Restrictions depend on finished product 9
10 fragrance compound à IFRA Code of Practice (1) The IFRA Code of Practice applies to the manufacture and handling of all fragrance materials, for all types of applications and contains the full set of IFRA Standards. The IFRA Code of Practice is no Regulation (soft law) A binding by the IFRA Code of Practice is only a prerequisite for all fragrance supplier companies that are members of IFRA (either directly or through national associations). 10
11 fragrance compound à IFRA Code of Practice (2) Amendments to the Code, if required, were issued annually until 2011, and are now issued every 2 years starting 2013, based on new scientific developments. These contain either new usage restrictions or revisions of existing usage restrictions. 47 th Amendment will be issued this spring (2013) 11
12 cosmetic product By definition a perfume as a finished product is a cosmetic product. As a cosmetic product a perfume should conform: à Regulation (EC) N 1223/2009 (cosmetic regulation) such as: > Product Information File new format > Notification new > Product claims (free of) new guidelines > Cosmetovigilance modified > Labeling requirements 12
13 cosmetic product > Product Information File new format (1) Regulation (EC) N 1223/ Article 11 and Annex I Fragrance suppliers deliver a specific file for each fragrance compound. This file will provide any information needed by cosmetic product manufacturer in order to establish its Product Information File. Nevertheless the exact fragrance formula won t be disclosed for confidentiality reason (intellectual property doesn t exist for fragrance formula) 13
14 cosmetic product > Product Information File new format (2) Annex I Cosmetic Product Safety Report A Cosmetic product safety information 1. Quantitative and qualitative composition of the cosmetic product 2. Physical/chemical characteristics and stability of the cosmetic product 3. Microbiological quality 4. Impurities, traces, information about the packaging material 5. Normal and reasonably forseeable use 6. Exposure to the cosmetic product 7. Exposure to the substances 8. Toxicogical profile of the substances 9. Undesirable effects and serious undesirable effects 10. Information on the cosmetic product B - Cosmetic product safety assessment 1. Assessment conclusion 2. Labelled warnings and instructions of use 3. Reasoning 14
15 cosmetic product > Product Information File new format (3) Essential Documents The fragrance compound must still be considered in the safety assessment of the finished product: Safety data sheet in compliance with the current EU regulation (> ) Reasoned evaluation of the safety of the fragrance compound for its intended use (see guidelines IFRA/COLIPA below) Certificate of compliance with IFRA standards currently in place (46th amendment) List of substances regulated in the annexes of the Cosmetic regulation: presence (INCI names)and concentration(inci names) Statement of compliance of the ingredients used in the compound with relevant EU chemical control legislation Guidelines on exchange of information between fragrance suppliers and cosmetic manufacturers Final pdf 15
16 cosmetic product > Notification / CPNP new Regulation (EC) N 1223/ Article 13 Prior to placing the cosmetic product on the market the responsible person shall notify it on the Cosmetic Product Notification Portal (CPNP). Different types of cosmetic product composition declarations: Predefined frame formulation The easiest for perfume Exact concentration Concentration ranges Fragrance composition will never be disclosed on CPNP. 16
17 cosmetic product > Product claims new guidelines (1) Regulation (EC) N 1223/ Article 20 The Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, Regulation on common criteria should be published next june and apply on July 11 th, Regulation (EU) n xx/xxx laying down common criteria for the justification of claims used in relation to cosmetic products «Free of» claims: shall become Annex II to the Regulation on the common criteria shall be published by the end of 2013 (with an update of above Regulation) 17
18 cosmetic product > Product claims new guidelines (2) «free of fragrance» Discussion on going - 2 positions The presence of a fragrance compound in a cosmetic product must be declared in the ingredients list by the INCI name 'parfum' or 'perfume'. Consequently, the claim 'fragrance-free' may not be made for any cosmetic that is required to declare 'parfum' or 'perfume' on the label. The claim 'fragrance-free' should not be made for any cosmetic that is required to label one or more of the 26 substances required to be labelled above certain threshold levels (allergens). In order to justify the use of the claim 'fragrance-free' in respect of a cosmetic product that is clearly not without smell, the manufacturer must be able to demonstrate that all the ingredient in the product from any source have a main function other than fragrance. For ingredients that are typically used in fragrances, like essential oils, the perfuming function should always be considered as one of the main functions. 18
19 cosmetic product > Product claims new guidelines (3) «hypoallergenic» The Federation believes that the industry should refrain from any denigrating message regarding the 26 allergens regardless of the type of product. For example, are not allowed expressions such as: - Number of "allergens" reduced. - Better tolerated because contains less "allergens". - Product formulated without "allergen". - "allergen" free perfume, hypoallergenic perfume. The word cannot be used for products whose main function is to perfume, would they contain alcohol or not. For example, are not allowed phrases like: - "Hypoallergenic perfume" - "Fragrance formulated to reduce / minimize the risk of allergy". 19
20 cosmetic product > Product claims new guidelines (4) «hypoallergenic» The word can be used for skincare products, hygiene or makeup only if: - The list of ingredients does not contain any of the 26 allergens listed in Annex III of the Cosmetic Regulation And - The product folder contains the necessary scientific evidence. BUT We still don t know European Commission and Member States will choose a definition of hypoallergenic. 20
21 cosmetic product > Cosmetovigilance (1) Article 23 Communication of serious undesirable effects 1. In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred: (a) all serious undesirable effects which are known to him or which may reasonably be expected to be known to him; (b) the name of the cosmetic product concerned, enabling its specific identification; (c) the corrective measures taken by him, if any. 21
22 cosmetic product > Cosmetovigilance (2) Article 23 Communication of serious undesirable effects 2. Where the responsible person/distributor reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member states Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer 22
23 cosmetic product > Cosmetovigilance (3) Definition of serious undesirable effects (SUE) Serious undesirable effects are defined as undesirable effects which result in: temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death. To be notified All SUE cases, except those classified as excluded in causality assessment Causality assessment is an analysis of causal association, on a case-by-case basis, in an attempt to determine the probability that a serious undesirable event is attributable to a well identified product used by an end user. 23
24 Regulatory requirements cosmetic product > Cosmetovigilance (4) Article 23 Consequences Most frequent undesirable effect: allergy to perfumes and hair dyes Serious undesirable effect will be declared: seriousness and causality to be assessed "before" any declaration. 24
25 cosmetic product > Cosmetovigilance (5) Article 23 Consequences Might require specialist medical assessment this is recommended in complex cases, the impact on the user s health is deemed serious. Will need additional examinations reliable and specific to the observed effect and performed by specialist physicians Possible questions from the responsible person and the competent authorities to the suppliers 25
26 "FAUX PROBLÈMES ET VRAIES QUESTIONS" SCCS opinion on fragrance allergens 26
27 SCCS opinion on fragrance allergens (1) Regulatory measures suggested by the SCCS opinion Ban of the fragrance ingredient Hydroxyisohexyl 3- cyclohexene carboxaldehyde (HICC) Ban of chloroatranol and atranol, which are constituents of oakmoss and treemoss. Restriction of use concentrations of eleven fragrance materials to 100 ppm. (eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, (DL)-Limonene, linalool, coumarine, cinnamal, cinnamyl alcohol, citral) Significant increase of scope for consumer information (allergen declaration) 27
28 SCCS opinion on fragrance allergens (2) Critical analysis of this opinion Classification of established allergens based on results of patch tests with no further analysis, without taking into account the level of exposure Comments on evidence and classification quality requirements for a study to be included in evaluation are low Assessment based on hazard not risk Regulatory measures focused on sensitized consumers 28
29 SCCS opinion on fragrance allergens (3) IFRA impact analysis of this opinion: economic 1. Ban of HICC and restrictions to 100ppm (65% of the European market represented): reformulation of fragrance formulae for perfumes (about 90%) cosmetics and toiletries (78% - 88%) would represent a total cost of approximately 364 M for the entire European fragrance industry. 2. Extended labelling Percentage of formulae concerned Leave on products: 99,5% Rinse off products: 96,2% For the best selling formulae the number of allergens to label Leave on products: from 7 to 21 Rinse off products: from 4 to 9 29
30 SCCS opinion on fragrance allergens (4) FEBEA impact analysis of this opinion IN FRANCE Ban of HICC Perfumes and: up to 75% fall with the turnover Other cosmetic products: 6650 formulae impacted Restriction to 100 ppm Perfumes up to 100% fall with turn over Other cosmetic product: about formulae impacted 30
31 SCCS opinion on fragrance allergens (5) Impact analysis of this opinion: economic but not only In terms of creativity, some of the allergens concerned are: critical (geraniol, citral, coumarin, linalool, limonen) important (hydroxycitronellal, eugenol, isoeugenol, cinnamal) Reduction of natural ingredients (essential oil of orange, bergamots, lemon, lavender ) 391 of the 536 natural ingredients used count at least one of the restricted ingredients at a level > 0.01% Would strongly affect the upstream industry, the agriculture sector (southern Europe) 31
32 SCCS opinion on fragrance allergens (6) Impact analysis of this opinion: creativity, innovation, upstream industry Disappearance of the European fragrance heritage linked to known fine fragrance brands Significant modification of the olfactive signature Uniformisation of fragrance notes on the EU market (disappearance of key olfactive families) Loss of quality and creative potential (natural ingredients are the only option to provide the high quality compositions for creating fine fragrances) Would generate massive costs and durably affect the competitiveness and innovation ability of the European fragrance industry. 32
33 SCCS opinion on fragrance allergens (7) Common industry positions for a regulatory follow up HICC: Allow a smooth phase-out of HICC by advocating a restriction to 100 ppm. However, this position has to be reconsidered, should the discussions around HICC risk to jeopardize the outcome of the remaining 11 substances, by far the more important and strategic ones. Atranol/chloroatranol: Reduce content to confirmed safe levels, which are still of benefit for the use of the material. 33
34 SCCS opinion on fragrance allergens (8) Common industry positions for a regulatory follow up Restriction of 11 allergens to 100ppm: Use QRA approach and apply restrictions based on induction risk assessment. Implement eventual refinements (such as aggregate exposures) according to recommendations from IFRA work plan. 34
35 SCCS opinion on fragrance allergens (9) Scope of consumer information Theoretical number of allergens (82 allergens i.e. Table 13.1) Application of a threshold for declaration (today 10/100ppm) Number of fragrance allergens to be declared per product 35
36 SCCS opinion on fragrance allergens (10) Consumer information: Industry objectives Equip DG Sanco with the elements for a constructive regulatory follow-up on consumer information, which is at the same time workable for the industry keeping the existing declaration threshold in the finished product (10/100ppm) addressing the full list of 82 ingredients, although via a step by step approach. The steps will be defined based on a substance by substance analysis with regard to analytical feasibility, safety parameters like allergy potency and exposure considerations 36
37 Thank you for your attention 37
Cosmetic products safety regulations
Cosmetic products safety regulations Trading Standards Information www.southwark.gov.uk 1. Introduction Cosmetic products are subject to EU wide safety regulations. They must not be liable to cause damage
More informationCosmetic Products Notification Portal (CPNP)
Cosmetic Products Notification Portal (CPNP) Article 13 1 User Manual This manual is intended for all CPNP users. It explains the main functions of the CPNP. 'CPNP users' means: - Cosmetic industry responsible
More informationOverview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Summary This document examines the key aspects of the CLP
More informationSupplying Cosmetic Products on the UK Market?
Supplying Cosmetic Products on the UK Market? A CTPA Guide to What You Need to Know March 2016 The Cosmetic, Toiletry and Perfumery Association Josaron House, 5/7 John Princes Street, London W1G 0JN tel:
More informationThe Cosmetics and Perfumery Association of Hong Kong Ltd. Position Paper. By Homer YU - Honorary Life President. Jacky Choi President
CB(1)1775/01-02(05) (Revised) The Cosmetics and Perfumery Association of Hong Kong Ltd. Position Paper By Homer YU - Honorary Life President Jacky Choi President Executive Committee Members Definition
More informationGuide to Distribution of Cosmetic Products in Ireland
Guide to Distribution of Cosmetic Products in Ireland ADV-G0012-2 17 JUNE 2013 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS
More informationAuthorisation and Restriction Newsletter
Authorisation and Restriction Newsletter August 2010, N 1 The information contained in this document is intended for guidance only and whilst the information is provided in utmost good faith and has been
More informationApplications of nanotechnology: Cosmetics
Applications of nanotechnology: Cosmetics Course on Health Effects of Engineered Nanomaterials Finnish Institute of Occupational Health, 23 April 2013 Sari Karjomaa Finnish Cosmetic, Toiletry and Detergent
More informationReport 340301002/2009 J. Ezendam J.D. te Biesebeek S.W.P. Wijnhoven. The presence of fragrance allergens in scented consumer products
Report 340301002/2009 J. Ezendam J.D. te Biesebeek S.W.P. Wijnhoven The presence of fragrance allergens in scented consumer products RIVM letter report 340301002/2009 The presence of fragrance allergens
More informationGUIDELINE ON THE CONTROL OF COSMETIC PRODUCTS
Revised July 2014 GUIDELINE ON THE CONTROL OF COSMETIC PRODUCTS The information in this Guideline shall be updated or revised from time-to-time. For any new, addition, amendments or deletion made to this
More informationEuropean Respiratory Society (ERS), The European Lung White Book Respiratory Health and Disease in Europe, 2013. 3
EFA response to the European Commission public consultation on fragrance allergens in the framework of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products The
More informationREACH and Safety Data Sheets
This leaflet explains the requirements for safety data sheets and how they will change in the future. What is REACH? REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is the
More informationSPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT
SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption
More informationIndustry proposal for a joint work plan
Industry proposal for a joint work plan Develop a shared common understanding of risk assessment methodologies, processes and criteria to identify fragrance allergens of concern Background Based on regular
More informationwww.cropwatch.org E: info@cropwatch.org T: ++44 (0)7771 872 521 THE FIRST TRULY INDEPENDENT WATCHDOG FOR THOSE WORKING WITH NATURAL AROMATIC MATERIALS
www.cropwatch.org THE FIRST TRULY INDEPENDENT WATCHDOG FOR THOSE WORKING WITH NATURAL AROMATIC MATERIALS E: info@cropwatch.org T: ++44 (0)7771 872 521 Cropwatch Claims Victory Regarding 26 Allergens Legislation.
More informationThe Increasing Regulatory World for Candles Global Key Issues. World Candle Congress 2016
The Increasing Regulatory World for Candles Global Key Issues World Candle Congress 2016 Knowing when to act, Keeping Candles Out of the Regulatory Spot Light! Confidential and proprietary business information
More informationCED GUIDELINES TO INTERPRET AND IMPLEMENT COUNCIL DIRECTIVE 2011/84/EU ON TOOTH WHITENING PRODUCTS
CED GUIDELINES TO INTERPRET AND IMPLEMENT COUNCIL DIRECTIVE 2011/84/EU ON TOOTH WHITENING PRODUCTS I INTRODUCTION This document provides guidance for interpreting and implementing the Council Directive
More informationThe new EU Regulation 1223/2009 on Cosmetic Products Everything you need to know! SCC Ontario March 25 th, 2014 Marie Roussel & Ariane Divetain
The new EU Regulation 1223/2009 on Cosmetic Products Everything you need to know! SCC Ontario March 25 th, 2014 Marie Roussel & Ariane Divetain INTRODUCTION TO THE REGULATION European Economic Area + European
More informationREPORT FOR INTERNATIONAL COOPERATION ON COSMETIC REGULATION (ICCR)
REPORT FOR INTERNATIONAL COOPERATION ON COSMETIC REGULATION (ICCR) Principles for the handling of traces of impurities and/or contaminants in cosmetic products Report is: 1 [Choose One] Prepared For ICCR
More informationMATERIAL SAFETY DATA SHEET
1. IDENTIFICATION OF SUBSTANCE / PREPARATION AND COMPANY PRODUCT NAMES : SUPPLIER : Imperial Leather - Handwash (UK) Japanese Spa Cotton Soft Citrus Burst Jasmine Touch Chamomile Care PZ CUSSONS (UK) LIMITED
More informationHow To Comply With The New Toy Directive
An Expert s View of the Implications of the Intertek, Centre Court, Meridian Business Park, Leicester LE19 1WD UK consumergoods.uk@intertek.com +44 (0)116 263 0330 www.intertek.com Implications of the
More informationL 94/16 Official Journal of the European Union 30.3.2012
L 94/16 Official Journal of the European Union 30.3.2012 REGULATION (EU) No 259/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 March 2012 amending Regulation (EC) No 648/2004 as regards the use
More informationApplication of TargetView software in the fragrance industry: Accurate identi cation of allergens with fast GC
Application Note: ANTV12 Application of TargetView software in the fragrance industry: Accurate identi cation of allergens with fast GC Introduction The need to screen consumer products for speci c organic
More informationBrussels, XXX [ ](2015) XXX draft ANNEX 1
EUROPEAN COMMISSION Brussels, XXX [ ](2015) XXX draft ANNEX 1 ANNEX EN EN ANNEX 'ANNEX VIII HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES 1. Application PART A
More informationINFORMATION FOR OBSERVERS. Project: Compliance Costs for REACH (Agenda Paper 3)
30 Cannon Street, London EC4M 6XH, United Kingdom Tel: +44 (0)20 7246 6410 Fax: +44 (0)20 7246 6411 E-mail: iasb@iasb.org Website: www.iasb.org International Accounting Standards Board This observer note
More informationCOMMISSION IMPLEMENTING DECISION
L 315/82 Official Journal of the European Union 26.11.2013 COMMISSION IMPLEMENTING DECISION of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of
More informationCOSMETIC PRODUCT SAFETY REPORT
1 Antigonis str 14451 Metamorfosis, Athens, Greece Tel : +30-210-2934745 e-mail : info@qacs.gr Fax : +30-210-2934606 web : www.qacs.gr COSMETIC PRODUCT SAFETY REPORT According to EC Regulation 1223/2009
More informationDETERGENTS REGULATION
European Commission Enterprise Directorate-General DETERGENTS REGULATION Regulation (EC) No 648/2004 Stephen Pickering Chemicals Unit, G.2 Enterprise and Industry Directorate-General Explanatory part of
More informationCOSMETIC PRODUCT SAFETY REPORT
1 Antigonis str 14451 Metamorfosis, Athens, Greece Tel : +30-210-2934745 e-mail : info@qacs.gr Fax : +30-210-2934606 web : www.qacs.gr COSMETIC PRODUCT SAFETY REPORT According to EC Regulation 1223/2009
More informationCONTROL PROCESS NATURAL ORIGIN AND ORGANIC CANDLES AND HOME FRAGRANCES
TS004(GPA)v03en v25/11/2015 CONTROL PROCESS NATURAL ORIGIN AND ORGANIC CANDLES AND HOME FRAGRANCES The aim of the present document is to describe the key steps of the control process. This document is
More informationOpinion of the Panel on food contact materials, enzymes, flavourings and processing aids (CEF)
The EFSA Journal (2009) 1208 Opinion of the Panel on food contact materials, enzymes, flavourings and processing aids (CEF) Guidelines on submission of a dossier for safety evaluation by the EFSA of active
More informationC162 Asbestos Convention, 1986
C162 Asbestos Convention, 1986 Convention concerning Safety in the Use of Asbestos (Note: Date of coming into force: 16:06:1989.) Convention:C162 Place:Geneva Session of the Conference:72 Date of adoption:24:06:1986
More informationCompilation of safety data sheets
GUIDANCE IN A NUTSHELL Compilation of safety data sheets The document aims to explain in simple terms the main principles and obligations relating to the compilation and provision of safety data sheets
More informationNewsletter Volume Two, 2010
Practical CLP Compliance Advice Given to EU Importers CLP stands for the Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of substances and mixtures. CLP introduces the United
More informationGHS - GLOBALLY HARMONIZED SYSTEM
GHS - GLOBALLY HARMONIZED SYSTEM of Classification and Labelling of Chemicals GHS is a system proposed by the United Nations (UN) for the harmonised world-wide classification and labelling of chemical
More informationToy Safety Directive 2009/48/EC
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Single Market for Goods Internal Market and its International Dimension Toy Safety Directive 2009/48/EC Technical documentation Version 1.3
More informationExplanatory notes VAT invoicing rules
Explanatory notes VAT invoicing rules (Council Directive 2010/45/EU) Why explanatory notes? Explanatory notes aim at providing a better understanding of legislation adopted at EU level and in this case
More informationCLP regulation & 2015 deadline for mixtures
CLP regulation & 2015 deadline for mixtures CEFIC REACH Information and Experience Exchange Forum Zaventem, 18 December 2013 Maurits-Jan Prinz European Commission DG Enterprise & Industry Table of contents
More informationEU ECOLABEL FOR ABSORBENT HYGIENE PRODUCTS
EU ECOLABEL FOR ABSORBENT HYGIENE PRODUCTS BEUC and EEB position on proposal to be voted on 14 th of March 2014 Contact: Blanca Morales environment@beuc.eu & blanca.morales@eeb.org Ref.: X/2014/014-05/03/2014
More informationTHE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT WITH HALF OPEN PATCH TEST
B (97/02/2016) THE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT WITH HALF OPEN PATCH TEST Product Biobellinda Permanent Hair Dye Cream 8.0 Light Auburn Biobellinda Kalıcı Krem Saç Boyası 8.0
More informationALLERGENS IN PERFUMES: GAS CHROMATOGRAPHY^ MASS SPECTROMETRY
1974 III / ALLERGENS IN PERFUMES: GAS CHROMATOGRAPHY^MASS SPECTROMETRY ALLERGENS IN PERFUMES: GAS CHROMATOGRAPHY^ MASS SPECTROMETRY S. C. Rastogi, National Environmental Research Institute, Rokilde, Denmark
More informationRbg Paris, Lilyrose, eau de parfum
SAFETY DATA SHEET According to regulation (EC) N 1907/2006 (as amended) This Safety Data Sheet cancels and replaces all preceding SDS for this product. 1) IDENTIFICATION OF THE STUBSTANCE/PREPARATION AND
More informationHelp Note for Dermatologists
Cosmetic Products Ingredient Labelling Help Note for Dermatologists Cosmetic Ingredient Labelling The legislation that regulates cosmetic products in the UK is the Cosmetic Products (Safety) Regulations
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2006R1907 EN 20.02.2009 004.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B C1 REGULATION (EC) No 1907/2006 OF THE EUROPEAN
More informationSECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING. Enzymatic Drain Cleaner and Maintainer
SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product name Product No. Enzymatic Drain Cleaner and Maintainer C187 1.2. Relevant identified uses
More informationB I L L. No. 183 An Act to amend The Saskatchewan Employment Act and The Saskatchewan Employment Amendment Act, 2014
B I L L No. 183 An Act to amend The Saskatchewan Employment Act and The Saskatchewan Employment Amendment Act, 2014 (Assented to ) HER MAJESTY, by and with the advice and consent of the Legislative Assembly
More informationSAFETY DATA SHEET EVO-STIK PLUMBERS MAIT
Revision Date November 2012 Revision 9 1 / 5 SAFETY DATA SHEET According to Regulation (EC) No 1907/2006 SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier
More informationSAFETY DATA SHEET ELEGANCE R.T.U.
SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product number Internal identification A089 EV Janitorial - Washroom
More informationSAFETY DATA SHEET Deb Protect Plus
Revision Date 15/02/2011 Supersedes date 08/02/2011 SAFETY DATA SHEET SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product name Product No.
More informationInformation leaflet Printing Inks for Food Packaging
Page 1 of 8 Information leaflet Printing Inks for Food Packaging 1. Introduction Food packaging is printed to provide information to the final consumer in accordance with Directive 2000/13/EC relating
More informationReference: HSHARP2IN1 Creation date: 27 November 2002 Page 1 of 7
MATERIAL SAFETY DATA SHEET Reference: HSHARP2IN1 Creation date: 27 November 2002 Page 1 of 7 1 IDENTIFICATION OF THE PRODUCT AND THE COMPANY PRODUCT : HARPIC TOILET BOWL CLEANER 2 IN 1 Company Reckitt
More informationPolyOne FAQs for the Globally Harmonized System (GHS) Safety Data Sheets (SDS) and Product Labeling.
General information on GHS and timelines Q1: What is GHS? GHS is short for Globally Harmonized System for Classification and Labeling of Chemicals, a framework designed to harmonize the very different
More informationGerman proposal for the restriction of PAHs in consumer products
Federal Institute for Occupational Safety and Health Dortmund, 04/06/2010 German proposal for the restriction of PAHs in consumer products 1. Introduction The government of the Federal Republic of Germany
More informationTITLE: Scent Sensitivity Procedure. SPONSOR: Vice-President, Finance & Administration
TITLE: Scent Sensitivity Procedure SPONSOR: Vice-President, Finance & Administration PREVIOUS VERSIONS: ACCOUNTABILITY: Office of Accountability: Safety and Risk Management Administrative Accountability:
More informationHAZARD COMMUNICATION PROGRAM PURPOSE
HAZARD COMMUNICATION PROGRAM PURPOSE The Occupational Safety and Health Administration (OSHA) has promulgated its Hazard Communication Standard (29CFR 1910.1200) to ensure that the hazards of all chemicals
More informationChemicals Regulation: A comparison of US and European Approaches. James Searles
Chemicals Regulation: A comparison of US and European Approaches James Searles April 11, 2011 www.steptoe.com April 11, 2011 TSCA vs.. REACH - OVERVIEW Both TSCA and REACH aim at gathering scientific information
More informationSpecimen Memo Fragrance Use
Specimen Memo Fragrance Use Our firm is concerned about an issue that is very important to the health of some of our staff. We hope by providing you with comprehensive information, you will be better able
More informationCivil Law Product Liability under REACH and CLP Some Basics
Civil Law Product Liability under REACH and CLP Some Basics Regulatory Services Zone Chemspec Europe, Budapest, 18 to 19 June 2014 Hans-Jochen Lueckefett MR a.d. Lawyer 2 AGENDA 1. New aspects of product
More informationProperties criteria - BETA
Properties criteria - BETA - according to Regulation (EC) No. 1272/2008 VALID FROM 01/06/2015 Introduction The BETA register is a part of the BASTA system. Products that are registered in the BETA register
More informationEnvironmental Monitoring
Environmental Monitoring For the import of oilseed rape from event T45 (ACS-BNØØ8-2) for food, feed and industrial uses 1. Introduction Authorisation holders have the obligation to implement, if appropriate,
More informationHaving regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;
DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of
More informationRisk assessment and regulation of tattoo inks in the EU
Risk assessment and regulation of tattoo inks in the EU Paul Janssen Current situation: Tattoo application in a regulatory vacuum : Is not a medical treatment Is not a cosmetic treatment No EU-regulation
More informationRegulatory requirements for Australia: Medicines, Cosmetics, Household Cleaning and Food Products RFA 2014
Regulatory requirements for Australia: Medicines, Cosmetics, Household Cleaning and Food Products Overview Regulation of medicines in Australia Regulation of cosmetic and household products in Australia
More informationSafety Data Sheet UN-GHS (Rev.4) (2011) Update: 21.05.2015 Version: 1.2
Solopol soft [ VERAPOL ] Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Solopol soft [ VERAPOL ] Hand cleanser free of solvent and friction
More informationMATERIAL SAFETY DATA SHEET Page 1 of 5
Page 1 of 5 SECTION 1. PRODUCT AND COMPANY IDENTIFICATION TRADE NAME: MANUFACTURER S NAME: Zotos International Inc. EMERGENCY #: (800) 584-8038 - 24 hours ADDRESS (NUMBER, STREET, CITY, STATE, & ZIP CODE):
More informationa white paper from Pete Trotman
a white paper from Pete Trotman The effects of biocides legislation on pest management A white paper on the effects of biocides regulation (EU) 528/2012 (BPR) on controlling rodent population This paper
More informationHaving regard to the Treaty establishing the European Community, and in particular Article 95(1) thereof,
L 268/24 REGULATION (EC) No 1830/2003 OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of
More informationOPINION on Fragrance allergens in cosmetic products
Scientific Committee on Consumer Safety SCCS OPINION on Fragrance allergens in cosmetic products The SCCS adopted this pre-consultation opinion at its 13 th plenary meeting of 13-14 December 2011 About
More informationGUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.
15 January 2007 GUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.) TABLE OF CONTENTS 1 INTRODUCTION... 2 2
More informationGHS CLP ATREAT. The new classification and labelling of hazardous chemicals. Providing a single source for your water treatment chemicals
GHS CLP The new classification and labelling of hazardous chemicals ATREAT Providing a single source for your water treatment chemicals Dear customer The current European system for classification and
More informationREACH and RoHS System Supplier Training
REACH and RoHS System Supplier Training 1 Background Increasingly, the EU and other international markets are restricting the presence of hazardous materials in products and packaging. Goal is to eliminate
More informationSafety data sheet according to 1907/2006/EC, Article 31
Page 1/6 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Article number: 1431345, 10024513, 9701421 1.2 Relevant identified uses of the substance
More informationEmpirical Formula: (C 14 H 20 NO 11 Na) n Chemical name : Sodium Hyaluronate
Rev. 02 of 06/12/12 Raw Material Data Sheet Page 1/ 5 PHYLCARE SODIUM HYALURONATE LW Cosmetic grade (I) Supplier name BIOPHIL ITALIA S.p.a. Via Celeste Milani, 26/28 21040 Origgio (Va) Italy (II) INCI
More informationHand Dishwashing Detergents
Good Environmental Choice Australia Managers of the Australian Ecolabel Program Final Standard No: GECA 15-2006 Issued: January 2006 The Australian Ecolabel Program Australian Voluntary Environmental Labelling
More informationCosmetic products in China
Cosmetic products in China Imported cosmetics need pre-market approval before entering China All cosmetics imported into China are required to obtain pre-market approval or notification from the Chinese
More informationGuidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device
Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation
More informationEURegulatory Compliance: Challenges and Solutions, EU CLP Regulation Overview.
EURegulatory Compliance: Challenges and Solutions, EU CLP Regulation Overview. Chris Sowden 3E Company 3E Company Provider of EH&S compliance and risk information management solutions Global EH&S domain
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)
European Medicines Agency Veterinary Medicines and Inspections London, 15 April 2005 EMEA/CVMP/134/02 Rev 1 CPMP/QWP/227/02 Rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY
More informationAutofoam SAFETY DATA SHEET
Page: 1 Section 1: Identification of the substance / mixture and company undertaking 1.1 Product identifier Product name: Autofoam 1.2 Relevant identified uses of the substance and mixture and uses advised
More informationRecommendation on how to handle product variants when selling online
In Europe Recommendation on how to handle product variants when selling online V1.0 - March 2014 www.gs1.eu Leadership in implementation 1 Foreword In this document GS1 explains the how regulation EU 1169/2011
More informationGUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
Foreword GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES These guidance notes do not aim to be a definite interpretation of National Laws and/or regulations and are for guidance purpose only.
More informationFast Analysis of Cosmetic Allergens Using UltraPerformance Convergence Chromatography (UPC 2 ) with MS Detection
Fast Analysis of Cosmetic Allergens Using UltraPerformance Convergence Chromatography (UPC 2 ) with MS Detection Jane Cooper, 1 Michael Jones, 1 and Stéphane Dubant 2 1 Waters Corporation, Wilmslow, UK
More informationHerbert Desel 2015-11-10
BUNDESINSTITUT FÜR RISIKOBEWERTUNG 6. BfR-Nutzerkonferenz European Cosmetic Products Notification Portal CPNP Erfahrungen mit der europäischen Datenbank zu Kosmetikmeldungen Modell für nationale Datenbank
More informationMATERIAL SAFETY DATA SHEET Finished Product.
MATERIAL SAFETY DATA SHEET Finished Product. SECTION 1 CHEMICAL SUBSTANCE/PRODUCT AND COMPANY IDENTIFICATION Finished Product Name: Ultra Sheen Extra Dry Hair Conditioner and Hair Dress (95460760) Company
More informationMaterial Safety Data Sheet According to 91/155 EC, 93/112/EC, 2001/58/EC
Page 1/5 1 Product and company identification Application of the product: Professional cleaning/maintenance product for building care. Manufacturer/Supplier: JohnsonDiversey local operating company Information
More informationSafety data sheet according to 1907/2006/EC, Article 31
Page 1/5 1 Identification of the substance/mixture and of the company/undertaking Product identifier Article number: 070-B Registration number Not applicable Application of the substance / the preparation
More informationSAFETY DATA SHEET BOSTIK AQUAGRIP 536
Revision Date November 2014 1 / 6 SAFETY DATA SHEET BOSTIK AQUAGRIP 536 According to Regulation (EC) No 1907/2006 SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1.
More informationGuide to Chemicals (Asbestos Articles) Regulations 2011. S.I. No. 248 of 2011
Guide to Chemicals (Asbestos Articles) Regulations 2011 S.I. No. 248 of 2011 Version 1 Guide to Chemicals (Asbestos Articles) Regulations 2011 Page 1 of 18 Table of Contents Introduction... 3 Background...
More informationREGULATION (EEC) No 2309/93
REGULATION (EEC) No 2309/93 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use
More informationDRAFT GUIDANCE DOCUMENT ON THE LOW VOLTAGE DIRECTIVE TRANSITION
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Industrial Transformation and Advanced Value Chains Advanced Engineering and Manufacturing Systems DRAFT
More informationGuide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical SUR-G0014-1 12 NOVEMBER 2013 This guide does not purport to be an interpretation of law and/or regulations
More informationAllergens of Special Interest
Chapter Allergens of Special Interest Jeanne Duus Johansen, Jean-Pierre Lepoittevin, David Basketter, John McFadden, Heidi Søsted Contents.1 Fragrances................... 507 Jeanne Duus Johansen, Jean-Pierre
More informationLiechtenstein. Heinz Frommelt. Sele Frommelt & Partners Attorneys at Law Ltd
Sele Frommelt & Partners Attorneys at Law Ltd Heinz Frommelt Sele Frommelt & Partners Attorneys at Law Ltd Legislation and jurisdiction 1 What is the relevant legislation and who enforces it? is a member
More informationMATERIAL SAFETY DATA SHEET Finished Product.
MATERIAL SAFETY DATA SHEET Finished Product. SECTION 1 - CHEMICAL SUBSTANCE/PRODUCT AND COMPANY IDENTIFICATION Finished Product Name: Fine Fragrances Eau de Toilette Natural Spray Products Applicable Brands
More informationSafety Data Sheet UN-GHS (Rev.4) (2011) Update: 21.05.2015 Version: 1.3
Kresto classic [ KRESTO ] Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Kresto classic [ KRESTO ] Hand cleanser containing solvent and friction
More informationThe certification process
TS004(COS)v01 The certification process for COSMOS standard Standard in force available on www.cosmos-standard.org or sent on request. 1 Contents I. When to apply... 3 II. The different steps in the certification
More informationConsolidated TEXT CONSLEG: 1991L0414 01/01/2004. produced by the CONSLEG system. of the Office for Official Publications of the European Communities
EN Consolidated TEXT produced by the CONSLEG system of the Office for Official Publications of the European Communities CONSLEG: 1991L0414 01/01/2004 Number of pages: 194 < Office for Official Publications
More informationProduct Data Sheet. Manufacturer: GW Cosmetics GmbH, A-2333 Leopoldsdorf, Achauer Strasse 49a; Austria, Europe.
RefectoCil Eyelash and Eyebrow Tint Blue Black 3 September 2013 / PS Page 1 of 2 Product: RefectoCil Eyelash and Eyebrow Tint Blue Black Formula code: FA 0020 Manufacturer: GW Cosmetics GmbH, ; Austria,
More informationSurvey of Chemical Substances in Consumer Products. Analysis of chemical hair-removal products. Survey no. 31 2003
Survey of Chemical Substances in Consumer Products Survey no. 31 2003 Analysis of chemical hair-removal products Anette Ejersted and Annette Orloff, the Danish Environmental Protection Agency 4 Contents
More information