Draft EAPCCT guidelines Review of information requirements

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Presentation transcript:

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

Poison Centres Informing the public and/or medical personnel about symptoms and treatment of acute intoxications Detailed product information necessary!

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

Draft EAPCCT guidelines 2010 Endorsed by the EAPCCT Board in September 2010 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 SDS SDS SDS Complete dataset

Safety Data Sheets SDS Add. Info PIC requirements 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 Additional information needed

Safety Data Sheets 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

Company information EAPCCT guidelines 2010 COMPANY INFORMATION - Company placing the mixture on the market Name and address. A unique company identifier. Possibilities - VAT number - Enterprise identification number - EORI number - EAN company code number - Company submitting the mixture information Name, address, telephone, e-mail. A unique company identifier. - Contact Point(s) in case of emergency For additional information. Department with telephone number/e-mail. Companies should set up internal procedures to cope with contacts with Poison Centres which may be needed in emergency situations. VAT number: Value Added Tax number. Unique in the EU with two letter country code. The full identifier starts with an ISO 3166-1 alpha-2 country code (except for Greece which uses the non-standard country code EL) and then has between 5 and 12 characters. These 5 to 12 characters are numeric in most countries but in some countries they may contain letters. Enterprise identification number: often based on VAT number. EORI (Economic Operator Registration and Identification) number from European Customs, mostly derived from existing enterprise identification numbers but adding the possibility of identifying foreign enterprises. Other possibilities: - Chamber of commerce number 24/7 availability might be difficult On the SDS: Poison Centre

Identification of the mixture Identification of the mixture is important! EAPCCT guidelines 2010 IDENTIFICATION OF THE MIXTURE - Mixture identifiers Authorisation number 6678N 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. 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. UBA number Product identification element recommended Mr Muscle Keuken Super Ontvetter Lemon Mr Muscle Cuisine Super Dégraissant Lemon

Identification of the mixture 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. Paints in many different colours Not allowed to group notifications for separately registered/authorized mixtures (pesticides/biocides). Reduce unnecessary workload! Only mixture with a common part in the trade name followed by an additional component indicating the specific variant, may be grouped. When mixture variants are grouped, all relevant mixture identifiers must be mentioned.

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

Composition EAPCCT guidelines 1989 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% Source: EAPCCT newsletter of April, 1996

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

Composition Substances in the mixture EAPCCT Guidelines 2010 COMPOSITION – Substances in the mixture (continued) Guideline based on article 18(2) of the CLP Regulation on the product identifier for a substance 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 The names ‘perfumes’, ‘fragrances’ and/or ‘colouring agents’ can be used. Substances occurring in nature: "essential oil of …" or "extract of …" The primary function of chemical nomenclature is to ensure that the person who hears or reads a chemical name is under no ambiguity as to which chemical compound it refers to: each name should refer to a single substance. Part 3 of Annex VI: HARMONISED CLASSIFICATION AND LABELLING TABLES Classification and labelling inventory: The Classification & Labelling (C&L) Inventory is a database that will contain basic classification and labelling information on notified and registered substances received from manufacturers and importers. It will also contain the list of harmonised classifications (Table 3.1 of Annex VI to CLP). The Inventory will be established and maintained by ECHA. You can submit your notification to the C&L Inventory already now but the public version of the Inventory will be available in 2011. IUPAC: is developed and kept up to date under the auspices of the International Union of Pure and Applied Chemistry (IUPAC). If available for a substance: - Chemical Abstracts Service (CAS) number - EC numbers (EINECS/ELINCS) are required. Identification of the substance Optional: - ‘functional group name’, - hazard classification (hazard class, category code, H-statements) - nanoformulated or not (yes/no). Priority for risk assessment

Composition Substance concentrations EAPCCT guidelines 1989 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% Source: EAPCCT newsletter of April, 1996

Composition Substance concentrations DUTCH SURVEY 2007 EAPCCT MSDS No guidelines Specified ranges Exact concentration and specified ranges Exact concentration 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

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 Health hazard classes Categories 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 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 1 2 1 1ABC 2 STOT single exposure R39: Danger of very serious irreversible effects R68: Possible risk of irreversible effects R37: Irritating to respiratory system R67: Vapours may cause drowsiness and dizziness STOT repeated exposure R48: Danger of serious damage to health by prolonged exposure 1 2 1 1 Danger Warning Signal words 1AB 2 1AB 2 1AB 2 * Specific Target Organ Toxicity

CLP health hazard classification From old to new classification: acute toxicity oral Directive 1999/45/EC Symbol Classification T+ R28 T R25 Xn R22 LD50 mg/kg < 5 5-25 25-50 50-200 200-300 300-2000 Categories Symbol Signal word Danger Warning Hazard statement Fatal if swallowed (H300) Toxic if swallowed (H301) Harmful if swallowed (H302) 1 2 3 4 CLP Regulation

Directly translating T+, T , C CLP Regulation (EC) No 1272/2008 Directive 1999/45/EC Health hazard classes Categories Classification 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 4 2 3 1 1 2 3 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 1 2 3 1 2 3 1 1 1ABC 1AB 1AB 1AB * Specific Target Organ Toxicity

New EAPCCT requirements CLP Regulation (EC) No 1272/2008 Health hazard classes Categories 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 4 3 1 2 1AB 1 2 3 EAPCCT guidelines 2010 COMPOSITION – Substances concentrations 1 2 3 1 2 3 Give actual concentrations of substances in the mixture classified as: 1 2 - acute toxicity (oral, dermal, inhalation), category 1, 2 and 3 1 2 - STOT – single/repeated exposure, category 1 and 2 1ABC - serious eye damage, category 1 - skin corrosion, category 1A, 1B and 1C 1 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% * Specific Target Organ Toxicity

Composition Reformulation EAPCCT guidelines 2010 COMPOSITION – Reformulation IN Substance 1 Substance 2 Substance If the mixture is reformulated and the name is unchanged, it is necessary to renew the notification to Poison Centres in case of: OUT Substance - the substitution or addition of one or more substances - the deletion of one or more substances Concentration: 3-10% 10-20% - change to other concentration bands - change of exact concentration above specified limit 20% 23% 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% Derived from CLP Regulation Review of classification of a mixture necessary If the name of the product is changed it will be a new notification

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

Classification Danger Warning H300: Fatal if swallowed EAPCCT guidelines 2010 CLASSIFICATION - Classification As provided on the SDS - Section 2.1 Label elements As provided on the SDS - Section 2.2 GHS05 H300: Fatal if swallowed T/T+ C GHS08 According to the new REACH Annex II, effective from 1-12-2010: At the moment classification is in Section 2 and ‘information shown on the label’ under the heading 15 ‘Regulatory information’. Danger GHS06 Xn/Xi GHS07 Immediately call a POISON CENTER or doctor/physician P310: Warning

Packaging 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 ‘A complete bottle that was one third full’

Physical/chemical characteristics 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. According to the new REACH Annex II, effective from 1-12-2010: At the moment Physical state is Section 9.1 and pH is Section 9.2

Toxicology Toxicological information on the current SDS is limited EAPCCT guidelines 2010 TOXICOLOGY 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 Toxicological information on the current SDS is limited Improvements expected from REACH From 1-12-2010 First amendment to REACH Annex II From 1-06-2015 Second amendment to REACH Annex II

REACH Regulation Improving protection of human health and the environment > 30.000 chemicals in EU market above 1 tonne per year Limited information on hazards and risks Registration of substances: Technical dossier Basic toxicological information 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 Information in SDS SECTION 11 + Annex

Toxicological information on the REACH SDS New Annex II: effective from June 2015

Toxicological information on the REACH SDS 11 This section primarily for: medical professionals, toxicologists... Information consistent with that provided in the registration and CSR 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 11.1 11.1.1 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 11.1.2 The data should describe the toxicological properties of the mixture as a whole 11.1.6 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 11.1.10 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 11.1.11.1 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: 11.1.11.2 if it is unlikely that these effects will occur at the concentrations present

Other information Product information form complete? EAPCCT guidelines 2010 OTHER INFORMATION Date of first marketing Date product information form completed Remarks Product information form complete?

Draft EAPCCT guidelines 2010 Summary COMPANY INFORMATION Company placing the mixture on the market Name, address, company identifier Company submitting the mixture information Name, address, telephone, e-mail, 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 - 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 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 SDS SDS

Thank you for your attention!