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European Association of Poisons Centres and Clinical Toxicologists Draft EAPCCT guidelines Review of information requirements Ronald de Groot National.

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Presentation on theme: "European Association of Poisons Centres and Clinical Toxicologists Draft EAPCCT guidelines Review of information requirements Ronald de Groot National."— Presentation transcript:

1 European Association of Poisons Centres and Clinical Toxicologists Draft EAPCCT guidelines Review of information requirements Ronald de Groot National Poisons Information Centre National Institute for Public Health and the Environment The Netherlands Workshop on the Harmonisation of Information for Poisons Centres - CLP Article 45(4) CLP - Regulation on Classification, Labelling and Packaging of Substances and Mixtures Brussels 24 November 2010

2 European Association of Poisons Centres and Clinical Toxicologists Detailed product information necessary! Informing the public and/or medical personnel about symptoms and treatment of acute intoxications Poison Centres

3 European Association of Poisons Centres and Clinical Toxicologists Developed by: Guidelines published in EAPCCT newsletter in 1996 Working Group on Poison Centres Activities / European Regulatory Issues Sub-Working Group on CLP issues 2009 First task: updating the EAPCCT guidelines 1989 EAPCCT guidelines 1989 European Poison Centres European household industry

4 European Association of Poisons Centres and Clinical Toxicologists COMPANY INFORMATION - Company placing the mixture on the market - Company submitting the mixture information - Contact Point(s) in case of emergency IDENTIFICATION OF THE MIXTURE - Mixture identifiers - Product Identification Element COMPOSITION - Substances in the mixture - Substance concentrations - Reformulation CATEGORISATION - Product Category - Consumer / Professional use CLASSIFICATION - Classification - Label elements PACKAGING - Type(s) - Size(s) - Labels PHYSICAL/CHEMICAL CHARATERISTICS - Physical state - pH - Total reserve acidity/alkalinity TOXICOLOGY OTHER INFORMATION Endorsed by the EAPCCT Board in September 2010 SDS Draft EAPCCT guidelines 2010 Complete dataset

5 European Association of Poisons Centres and Clinical Toxicologists SDS Additional information needed PIC requirements Add. Info Safety Data Sheets For companies: Convenient to use the Safety Data Sheet as part of the product information For Poison Centres: Not enough information on the SDS to perform an adequate risk assessment

6 European Association of Poisons Centres and Clinical Toxicologists Intended for the professional user Dangerous substances above thresholds of 0,1% or 1% depending on hazard classification Substances not classified don't have to be mentioned Concentration ranges allowed Toxicological information in the current SDS is limited Safety Data Sheets

7 European Association of Poisons Centres and Clinical Toxicologists EAPCCT guidelines 2010 COMPANY INFORMATION - Company placing the mixture on the market Name and address. A unique company identifier. - Company submitting the mixture information Name, address, telephone, . A unique company identifier. - Contact Point(s) in case of emergency For additional information. Department with telephone number/ . Companies should set up internal procedures to cope with contacts with Poison Centres which may be needed in emergency situations. Company information Possibilities - VAT number - Enterprise identification number - EORI number - EAN company code number 24/7 availability might be difficult On the SDS: Poison Centre

8 European Association of Poisons Centres and Clinical Toxicologists EAPCCT guidelines 2010 IDENTIFICATION OF THE MIXTURE - Mixture identifiers Other names or synonyms by which the mixture is labelled or commonly known (alternative names). Different names in the same country (e.g. different languages). If available, also mention other mixture identifiers present on the label. Specify the type of identifier. Complete trade name(s) as present on the label (if relevant including brand name, product line, name of the product and variant name) without abbreviations, enabling its specific identification. Identification of the mixture is important! Identification of the mixture UBA number Mr Muscle Keuken Super Ontvetter Lemon Mr Muscle Cuisine Super Dégraissant Lemon Authorisation number 6678N Product identification element recommended

9 European Association of Poisons Centres and Clinical Toxicologists EAPCCT guidelines 2010 IDENTIFICATION OF THE MIXTURE - Mixture identifiers (continued) On the grouping of mixtures: Grouping of mixtures is allowed when variants - have essentially the same composition - only differ in colour and/or fragrance. Grouping is not allowed if substances, for which an exact concentration is required, differ, either in presence or concentration, between variants. Not allowed to group notifications for separately registered/authorized mixtures (pesticides/biocides). When mixture variants are grouped, all relevant mixture identifiers must be mentioned. Only mixture with a common part in the trade name followed by an additional component indicating the specific variant, may be grouped. Identification of the mixture Paints in many different colours Reduce unnecessary workload!

10 European Association of Poisons Centres and Clinical Toxicologists For an adequate risk assessment in case of intoxications with a mixture, detailed information on the composition is necessary Product Amount Patient Composition Article 45:... This information shall include the chemical composition of mixtures... … all information … to carry out the tasks for which they are responsible.

11 European Association of Poisons Centres and Clinical Toxicologists All constituents should be mentioned Actual concentrations of any very toxic (T + ), toxic (T) or corrosive (C) constituents Concentrations of all other constituents can be given in % concentration bands: 0 to 1%20 to 30% 1 to 5%30 to 50% 5 to 10%50 to 75% 10 to 20%over 75% EAPCCT guidelines 1989 Source: EAPCCT newsletter of April, 1996 Composition

12 European Association of Poisons Centres and Clinical Toxicologists Mention all substances (whatever their toxicity), impurities and stabilising additives, by internationally accepted chemical names, present in the mixture when placed on the market. EAPCCT guidelines 2010 COMPOSITION – Substances in the mixture MSDS Thresholds for dangerous substances Thresholds for all substances Exact composition EAPCCT Composition Substances in the mixture DUTCH SURVEY 2007 For detergents according to Article 8(3) of Regulation (EC) No 648/2004 Complete ingredient list available for medical personnel

13 European Association of Poisons Centres and Clinical Toxicologists Guideline on the use of internationally accepted chemical names, in descending order of preference: - Part 3 of Annex VI of the CLP Regulation - classification and labelling inventory - IUPAC name - another international chemical name EAPCCT Guidelines 2010 COMPOSITION – Substances in the mixture (continued) The names perfumes, fragrances and/or colouring agents can be used. Substances occurring in nature: "essential oil of …" or "extract of …" If available for a substance: - Chemical Abstracts Service (CAS) number - EC numbers (EINECS/ELINCS) are required. Composition Substances in the mixture Guideline based on article 18(2) of the CLP Regulation on the product identifier for a substance Identification of the substance Priority for risk assessment Optional: - functional group name, - hazard classification (hazard class, category code, H-statements) - nanoformulated or not (yes/no).

14 European Association of Poisons Centres and Clinical Toxicologists All constituents should be mentioned Actual concentrations of any very toxic (T + ), toxic (T) or corrosive (C) constituents Concentrations of all other constituents can be given in % concentration bands: 0 to 1%20 to 30% 1 to 5%30 to 50% 5 to 10%50 to 75% 10 to 20%over 75% EAPCCT guidelines 1989 Source: EAPCCT newsletter of April, 1996 Composition Substance concentrations

15 European Association of Poisons Centres and Clinical Toxicologists MSDS No guidelines Specified ranges Exact concentration and specified ranges Exact concentration EAPCCT The notification of exact concentrations for all substances in a mixture is preferred Defining for which substances exact concentrations are required Direct translation of EAPCCT guidelines 1989: T +, T and C Looking anew to the classification according to CLP Regulation Composition Substance concentrations DUTCH SURVEY 2007

16 European Association of Poisons Centres and Clinical Toxicologists Acute toxicity Oral Acute toxicity Dermal Acute toxicity Inhalation STOT* - single exp STOT* - repeated exp Aspiration hazard Skin corrosion/irritation Eye damage/irritation Respiratory sensitisation Skin sensitisation Carcinogenicity Mutagenicity Reproductive toxicity Effect during lactation ABC AB Health hazard classesCategories * Specific Target Organ Toxicity Danger Warning Signal words CLP health hazard classification CLP Regulation (EC) No 1272/2008 T + R28 / T R25 / Xn R22 T + R27 / T R24 / Xn R21 T + R26 / T R23 / Xn R20 T + R39 / T R39 / Xn R68 / R37 / R67 T R48 / Xn R48 Xn R65 C R35 / C R34 / Xi R38 Xi R41 / Xi R36 Xn R42 Xi R43 cat.1/2 (T R45/R49) / cat.3 (Xn R40) cat.1/2 (T R46) / cat. 3 (Xn R68) cat.1/2 (T R60/R61) / cat.3 (Xn R62/R63) R64 Classification Directive 1999/45/EC

17 European Association of Poisons Centres and Clinical Toxicologists Directive 1999/45/EC LD 50 mg/kg Classification Symbol T + R28T R25Xn R22 Categories Symbol Signal word Danger Warning Hazard statement Fatal if swallowed (H300) Toxic if swallowed (H301) Harmful if swallowed (H302) CLP Regulation < From old to new classification: acute toxicity oral CLP health hazard classification

18 European Association of Poisons Centres and Clinical Toxicologists Acute toxicity Oral Acute toxicity Dermal Acute toxicity Inhalation STOT* - single exp STOT* - repeated exp Aspiration hazard Skin corrosion/irritation Eye damage/irritation Respiratory sensitisation Skin sensitisation Carcinogenicity Mutagenicity Reproductive toxicity Effect during lactation ABC 1AB CLP Regulation (EC) No 1272/2008 1AB Health hazard classesCategories T + R28 / T R25 / Xn R22 T + R27 / T R24 / Xn R21 T + R26 / T R23 / Xn R20 T + R39 / T R39 / Xn R68 / R37 / R67 T R48 / Xn R48 Xn R65 C R35 / C R34 / Xi R38 Xi R41 / Xi R36 Xn R42 Xi R43 cat.1/2 (T R45/R49) / cat.3 (Xn R40) cat.1/2 (T R46) / cat. 3 (Xn R68) cat.1/2 (T R60/R61) / cat.3 (Xn R62/R63) R64 Directive 1999/45/EC Classification * Specific Target Organ Toxicity Directly translating T +, T, C

19 European Association of Poisons Centres and Clinical Toxicologists Acute toxicity Oral Acute toxicity Dermal Acute toxicity Inhalation STOT* - single exp STOT* - repeated exp Aspiration hazard Skin corrosion/irritation Eye damage/irritation Respiratory sensitisation Skin sensitisation Carcinogenicity Mutagenicity Reproductive toxicity Effect during lactation ABC AB Health hazard classesCategories * Specific Target Organ Toxicity Give actual concentrations of substances in the mixture classified as: EAPCCT guidelines 2010 COMPOSITION – Substances concentrations For all other substances in the mixture concentration bands: 0-0,1%, 0,1-1%, 1-3%, 3-10%, 10-20% 20-30%, 30-50%, 50-75%, >75% New EAPCCT requirements CLP Regulation (EC) No 1272/ STOT – single/repeated exposure, category 1 and 2 - serious eye damage, category 1 - skin corrosion, category 1A, 1B and 1C - acute toxicity (oral, dermal, inhalation), category 1, 2 and 3

20 European Association of Poisons Centres and Clinical Toxicologists If the mixture is reformulated and the name is unchanged, it is necessary to renew the notification to Poison Centres in case of: - the substitution or addition of one or more substances - change to other concentration bands - change of exact concentration above specified limit - the deletion of one or more substances If the name of the product is changed it will be a new notification Initial concentration range of substance: Renotification necessary if initial concentration of the substance changes by more than: C 2,5 %30% 2,5 < C 10 %20% 10 < C 25 %10% 25 < C 100 %5% EAPCCT guidelines 2010 COMPOSITION – Reformulation IN Substance 1Substance 2 Substance Derived from CLP Regulation OUTSubstance Concentration: 3-10% 10-20% 20% 23% Review of classification of a mixture necessary Composition Reformulation

21 European Association of Poisons Centres and Clinical Toxicologists - Product Category Describe the intended use of the mixture. Ideally a harmonised categorisation system should be developed by the EAPCCT in collaboration with industry. EAPCCT guidelines 2010 CATEGORISATION - Consumer/Professional use Specify if the mixture is for consumer and/or professional use. - Chemical products - Cleaning products - Dishwasher detergents Annual European poisoning report Comparing poisonings between countries In the future: Categorisation

22 European Association of Poisons Centres and Clinical Toxicologists Danger Warning EAPCCT guidelines 2010 CLASSIFICATION - Classification As provided on the SDS - Section Label elements As provided on the SDS - Section 2.2 Classification H300: Fatal if swallowed GHS06 GHS05 GHS07 GHS08 Immediately call a POISON CENTER or doctor/physician P310: X n /X i C T/T +

23 European Association of Poisons Centres and Clinical Toxicologists EAPCCT guidelines 2010 PACKAGING - Type(s) - Size(s) Mention the type and size of packaging. The type and size may influence toxic hazard. - Labels Providing labels is preferred, particularly for products with a health hazard classification according to Regulation (EC) No 1272/2008 Packaging A complete bottle that was one third full

24 European Association of Poisons Centres and Clinical Toxicologists EAPCCT guidelines 2010 PHYSICAL/CHEMICAL CHARACTERISTICS - Physical state As provided on the SDS - Section 9.1(a) - pH As provided on the SDS - Section 9.1(d) - total reserve acidity/alkalinity If available, give total reserve acidity/alkalinity of product where relevant. Physical/chemical characteristics

25 European Association of Poisons Centres and Clinical Toxicologists Toxicological information on the current SDS is limited Improvements expected from REACH Note to industry: relevant information on the toxicity of the mixture is important for Poison Centres and should be provided according to the Regulation 1907/2006 on the Safety Data Sheet EAPCCT guidelines 2010 TOXICOLOGY Toxicology First amendment to REACH Annex II From Second amendment to REACH Annex II From

26 European Association of Poisons Centres and Clinical Toxicologists Improving protection of human health and the environment > chemicals in EU market above 1 tonne per year Limited information on hazards and risks Registration of substances: Basic toxicological information Technical dossier Information in SDS SECTION 11 + Annex Chemical Safety Report (CSR) Human health hazard assessment: Exposure assessment: Evaluation of non-human information Evaluation of human information Classification and Labelling Derivation of DNELs Exposure scenario(s) Exposure estimation REACH Regulation

27 European Association of Poisons Centres and Clinical Toxicologists New Annex II: effective from June 2015 Toxicological information on the REACH SDS

28 European Association of Poisons Centres and Clinical Toxicologists This section primarily for: medical professionals, toxicologists... Information consistent with that provided in the registration and CSR 11 Relevant hazard classes, for which information shall be provided: Acute toxicity Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT-single exposure STOT-repeated exposure Aspiration hazard If the mixture is not classified for a particular hazard class, the reason should be stated: - Lack of data - Technical impossibility - Inconclusive data - Based on available data, the classification critera are not met Toxicological information on the REACH SDS

29 European Association of Poisons Centres and Clinical Toxicologists The data should describe the toxicological properties of the mixture as a whole Symptoms from lowest exposure to severe exposure shall be described If a mixture has not been tested for its health effects as a whole, relevant information on relevant substances shall be provided Overall toxicity of the mixture may be different from that of the substances in it This shall be taken into account when providing the toxicological information It is necessary to consider whether the concentration of each substance is sufficient to contribute to the overall health effects of the mixture Information on toxic effects shall be presented for each substance, except: if it is unlikely that these effects will occur at the concentrations present Toxicological information on the REACH SDS

30 European Association of Poisons Centres and Clinical Toxicologists Date of first marketing Date product information form completed Remarks EAPCCT guidelines 2010 OTHER INFORMATION Other information Product information form complete?

31 European Association of Poisons Centres and Clinical Toxicologists COMPANY INFORMATION - Company placing the mixture on the market Name, address, company identifier - Company submitting the mixture information Name, address, telephone, , fax, company identifier - Contact Point(s) in case of emergency IDENTIFICATION OF THE MIXTURE - Mixture identifiers Mention the complete trade name(s) (in all relevant languages of the country of marketing) Other mixture identifiers present on the label (type should be specified) Under special conditions grouping of mixture variants is allowed. - Product identification element A unique product identification element is highly recommended COMPOSITION - Substances in the mixture Mention all substances (whatever their toxicity) present in the mixture. Names perfumes, fragrances, colouring agents, essential oil of … and extract of … can be used. Required: CAS- and EC (EINECS/ELINCS) number (if available) Optional: functional group name, hazard classification, H-statements, nanoformulated yes/no Draft EAPCCT guidelines 2010 Summary

32 European Association of Poisons Centres and Clinical Toxicologists - Substance concentrations Actual concentrations for substances classified as - acute toxicity (oral, dermal, inhalation), category 1,2 and 3 - STOT single/repeated, category 1 and 2 - skin corrosion, category 1A, 1B and 1C - serious eye damage, category 1 Specified concentration bands for other substances: 0-0,1%, 0,1-1%, 1-3%, 3-10%, 10-20%, 20-30%, 30-50%, 50-75%, >75% Exact concentration for all substances is preferred but voluntary - Reformulation rules - substitution, addition or deletion of one or more substances - change to other concentration bands - change of exact concentration above specified limit (when review of classification is necessary) CATEGORISATION - Product Category Describe the intended use of the mixture. - Consumer / Professional use Draft EAPCCT guidelines 2010 Summary

33 European Association of Poisons Centres and Clinical Toxicologists CLASSIFICATION - Classification - Label Elements PACKAGING - Type(s) - Size(s) - Labels PHYSICAL/CHEMICAL CHARACTERISTICS - Physical state - pH -Total reserve acidity/alkalinity (If available). TOXICOLOGY Supplied on the SDS and expected to improve with future requirements from the REACH Regulation OTHER INFORMATION - Date of first marketing. - Date product information form completed. - Remarks SDS Draft EAPCCT guidelines 2010 Summary

34 European Association of Poisons Centres and Clinical Toxicologists Thank you for your attention!


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