Post on 27-Mar-2015
European Association of Poisons Centres and Clinical Toxicologists
Draft EAPCCT guidelinesReview of information requirements
Ronald de Groot
National Poisons Information CentreNational 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 MixturesBrussels 24 November 2010
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
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 CentresEuropean household industry
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
SDS
SDS
Draft EAPCCT guidelines 2010
Complete dataset
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
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
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT guidelines 2010COMPANY INFORMATION
- Company placing the mixture on the market Name and address.A unique company identifier.
- Company submitting the mixture informationName, 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.
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
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT guidelines 2010IDENTIFICATION 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 mixtureis 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
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT guidelines 2010IDENTIFICATION 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!
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. “
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 constituentscan 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
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 2010COMPOSITION
– Substances in the mixture
MSDS
Thresholds fordangerous substances
Thresholds forall 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 listavailable for medical personnel
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 2010COMPOSITION – 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).
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 constituentscan 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
European Association of Poisons Centres and Clinical Toxicologists
MSDS
No guidelines Specified ranges Exact concentrationand 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
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
1 2 3 4
1 2 3 4
1 2 3 4
1 2 3
1 2
1
1ABC 2
1 2
1
1
1AB 2
2
2
1AB
1AB
Health hazard classes Categories
* 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
European Association of Poisons Centres and Clinical Toxicologists
Directive1999/45/EC
LD50 mg/kg
Classification
Symbol
T+ R28 T R25 Xn R22
Categories
Symbol
Signal word
Danger Danger Danger Warning
Hazardstatement
Fatal if swallowed(H300)
Toxic if swallowed(H301)
Harmful if swallowed(H302)
1 2 3 4
CLPRegulation
< 5 5-25 25-50 50-200 200-300 300-2000
From old to new classification: acute toxicity oral
CLP health hazard classification
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
1 2 3
1 2 3
1 2 3
1
1
1ABC
1AB
4
4
4
2 3
2
1
2
1 2
1
1
2
2
2
CLP Regulation (EC) No 1272/2008
1AB
1AB
Health hazard classes Categories
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/ECClassification
* Specific Target Organ Toxicity
Directly translating T+, T , C
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
1 2 3
1 2 3
1 2 3
1 2
1 2
1ABC
1
4
4
4
3
1
2
2
1
1
1AB 2
2
2
1AB
1AB
Health hazard classes Categories
* Specific Target Organ Toxicity
Give actual concentrations of substances in the mixture classified as:
EAPCCT guidelines 2010COMPOSITION – 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 1272/2008
- 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
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 initialconcentration of the substancechanges by more than:
C ≤ 2,5 % 30%
2,5 < C ≤ 10 % 20%
10 < C ≤ 25 % 10%
25 < C ≤ 100 % 5%
EAPCCT guidelines 2010COMPOSITION – Reformulation
IN
Substance 1 Substance 2
Substance
Derived from CLP Regulation
OUT Substance
Concentration:
3-10% 10-20%
20% 23%
Review of classification of a mixture necessary
Composition Reformulation
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 2010CATEGORISATION
- Consumer/Professional use Specify if the mixture is for consumer and/or professional use.
- Chemical products- Cleaning products
- Dishwasher detergents
Annual European poisoning reportComparing poisonings between countries
In the future:
Categorisation
European Association of Poisons Centres and Clinical Toxicologists
Danger
Warning
EAPCCT guidelines 2010CLASSIFICATION
- Classification As provided on the SDS - Section 2.1
- Label elementsAs 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:
Xn/Xi
CT/T+
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT guidelines 2010PACKAGING
- 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’
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT guidelines 2010PHYSICAL/CHEMICAL CHARACTERISTICS
- Physical stateAs provided on the SDS - Section 9.1(a)
- pHAs 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
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 mixtureis important for Poison Centres and should be provided accordingto the Regulation 1907/2006 on the Safety Data Sheet
EAPCCT guidelines 2010TOXICOLOGY
Toxicology
First amendment to REACH Annex IIFrom 1-12-2010
Second amendment to REACH Annex IIFrom 1-06-2015
European Association of Poisons Centres and Clinical Toxicologists
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:
• 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
European Association of Poisons Centres and Clinical Toxicologists
New Annex II: effective from June 2015
Toxicological information on the REACH SDS
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
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
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
11.1.2
11.1.6
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
Toxicological information on the REACH SDS
European Association of Poisons Centres and Clinical Toxicologists
Date of first marketingDate product information form completedRemarks
EAPCCT guidelines 2010OTHER INFORMATION
Other information
Product information form complete?
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, 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 2010Summary
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 2010Summary
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).
TOXICOLOGYSupplied 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
Draft EAPCCT guidelines 2010Summary
European Association of Poisons Centres and Clinical Toxicologists
Thank you for your attention!