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

3. 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

4. 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

5. 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

6. 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

7. 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, . 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.
VAT number: Value Added Tax number. Unique in the EU with two letter country code.
The full identifier starts with an ISO 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

8. 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

9. 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.

10. 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. “

11. 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

12. 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.

13. 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

14. 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

15. 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

16. 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

17. 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
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

18. 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

19. 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

20. 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% %
- change to other concentration bands
- change of exact concentration above specified limit
20% %
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

21. 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

22. 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 :
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

23. 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’

24. 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 :
At the moment Physical state is Section 9.1 and pH is Section 9.2

25. 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
First amendment to REACH Annex II
From
Second amendment to REACH Annex II

26. REACH Regulation
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:
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

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

28. Toxicological information on the REACH SDS11
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

29. 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
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

30. 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?

31. 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, , 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

32. Draft EAPCCT guidelines 2010 Summary
- Substance concentrations
Actual concentrations for substances classified as
- acute toxicity (oral, dermal, inhalation), category 1,2 and STOT single/repeated, category 1 and 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

33. 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

34. Thank you for your attention!