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.

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
European Association of Poisons Centres and Clinical Toxicologists
Poison Centres
Informing the public and/or medical personnel about
symptoms and treatment of acute intoxications
Detailed product information necessary!
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT guidelines 1989
Developed by:
European Poison Centres
European household industry
Guidelines published in EAPCCT newsletter in 1996
2009
Working Group on Poison Centres Activities /
European Regulatory Issues
Sub-Working Group on CLP issues
First task: updating the EAPCCT guidelines 1989
European Association of Poisons Centres and Clinical Toxicologists
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
CLASSIFICATION
- Classification
- Label elements
SDS
IDENTIFICATION OF THE MIXTURE
- Mixture identifiers
- Product Identification Element
PACKAGING
- Type(s)
- Size(s)
- Labels
COMPOSITION
- Substances in the mixture
- Substance concentrations
- Reformulation
PHYSICAL/CHEMICAL CHARATERISTICS
- Physical state
SDS
- pH
- Total reserve acidity/alkalinity
CATEGORISATION
- Product Category
- Consumer / Professional use
TOXICOLOGY
OTHER INFORMATION
Complete dataset
European Association of Poisons Centres and Clinical Toxicologists
SDS
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
European Association of Poisons Centres and Clinical Toxicologists
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
European Association of Poisons Centres and Clinical Toxicologists
Company information
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, e-mail.
A unique company identifier.
Possibilities
- VAT number
- Enterprise identification number
- EORI number
- EAN company code number
- Contact Point(s) in case of emergency
For additional information.
Department with telephone number/e-mail.
24/7 availability
might be difficult
Companies should set up internal procedures to
cope with contacts with Poison Centres which may
be needed in emergency situations.
On the SDS:
Poison Centre
European Association of Poisons Centres and Clinical Toxicologists
Identification of the mixture
Identification
of the mixture
is important!
EAPCCT guidelines 2010
IDENTIFICATION OF THE MIXTURE
- Mixture identifiers
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).
6678N
Different names in the same country
(e.g. different languages).
Authorisation number
If available, also mention other mixture identifiers
present on the label. Specify the type of identifier.
Product identification element recommended
Mr Muscle Keuken Super Ontvetter Lemon
Mr Muscle Cuisine Super Dégraissant Lemon
UBA number
European Association of Poisons Centres and Clinical Toxicologists
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).
Only mixture with a common part in the trade
name followed by an additional component
indicating the specific variant, may be grouped.
Reduce unnecessary workload!
When mixture variants are grouped, all relevant
mixture identifiers must be mentioned.
European Association of Poisons Centres and Clinical Toxicologists
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. “
European Association of Poisons Centres and Clinical Toxicologists
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%
1 to 5%
5 to 10%
10 to 20%
Source: EAPCCT newsletter of April, 1996
20 to 30%
30 to 50%
50 to 75%
over 75%
European Association of Poisons Centres and Clinical Toxicologists
Composition
Substances in the mixture
DUTCH SURVEY 2007
MSDS
EAPCCT
Thresholds for
dangerous substances
Thresholds for
all substances
EAPCCT guidelines 2010
COMPOSITION
– Substances in the mixture
Mention all substances (whatever their toxicity), impurities and
stabilising additives, by internationally accepted chemical names,
present in the mixture when placed on the market.
Exact composition
For detergents
according to Article 8(3) of
Regulation (EC) No 648/2004
Complete ingredient list
available for medical
personnel
European Association of Poisons Centres and Clinical Toxicologists
Composition
Substances in the mixture
EAPCCT Guidelines 2010
COMPOSITION
– Substances in the mixture (continued)
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
Guideline based on
article 18(2) of the
CLP Regulation on the
product identifier for
a substance
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.
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
European Association of Poisons Centres and Clinical Toxicologists
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%
1 to 5%
5 to 10%
10 to 20%
Source: EAPCCT newsletter of April, 1996
20 to 30%
30 to 50%
50 to 75%
over 75%
European Association of Poisons Centres and Clinical Toxicologists
Composition
Substance concentrations
DUTCH SURVEY 2007
MSDS
No guidelines
EAPCCT
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
European Association of Poisons Centres and Clinical Toxicologists
CLP health hazard classification
CLP Regulation (EC) No 1272/2008
Directive 1999/45/EC
Health hazard classes
Classification
Categories
Acute toxicity Oral
1
2
3
4
T+ R28 / T R25 / Xn R22
Acute toxicity Dermal
1
2
3
4
T+ R27 / T R24 / Xn R21
Acute toxicity Inhalation
1
2
3
4
T+ R26 / T R23 / Xn R20
STOT* - single exp
1
2
3
STOT* - repeated exp
1
2
Aspiration hazard
1
T+ R39 / T R39 / Xn R68 / R37 / R67
T R48 / Xn R48
Xn R65
1ABC
2
C R35 / C R34 / Xi R38
Eye damage/irritation
1
2
Xi R41 / Xi R36
Respiratory sensitisation
1
Skin sensitisation
1
Skin corrosion/irritation
Xn R42
Carcinogenicity
1AB
2
Mutagenicity
1AB
2
Reproductive toxicity
1AB
2
Signal words
Danger
Warning
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)
European Association of Poisons Centres and Clinical
Effect during lactation
R64 Toxicologists
* Specific Target Organ Toxicity
CLP health hazard classification
From old to new classification: acute toxicity oral
Directive
1999/45/EC
Symbol
Classification
T+ R28
LD50 mg/kg
<5
Categories
1
T R25
25-50
5-25
2
Xn R22
200-300
50-200
3
300-2000
4
Symbol
CLP
Regulation
Signal
word
Danger
Hazard
statement
Fatal if swallowed
(H300)
Danger
Danger
Warning
Toxic if swallowed
(H301)
Harmful if swallowed
(H302)
European Association of Poisons Centres and Clinical Toxicologists
Directly translating T+, T , C
CLP Regulation (EC) No 1272/2008
Directive 1999/45/EC
Health hazard classes
Classification
Categories
Acute toxicity Oral
1
2
3
4
T+ R28 / T R25 / Xn R22
Acute toxicity Dermal
1
2
3
4
T+ R27 / T R24 / Xn R21
Acute toxicity Inhalation
1
2
3
4
T+ R26 / T R23 / Xn R20
STOT* - single exp
1
2
3
STOT* - repeated exp
1
2
Aspiration hazard
1
T+ R39 / T R39 / Xn R68 / R37 / R67
T R48 / Xn R48
Xn R65
1ABC
2
C R35 / C R34 / Xi R38
Eye damage/irritation
1
2
Xi R41 / Xi R36
Respiratory sensitisation
1
Xn R42
Skin sensitisation
1
Xi R43
Skin corrosion/irritation
Carcinogenicity
1AB
2
cat.1/2 (T R45/R49) / cat.3 (Xn R40)
Mutagenicity
1AB
2
cat.1/2 (T R46) / cat. 3 (Xn R68)
Reproductive toxicity
1AB
2
cat.1/2 (T R60/R61) / cat.3 (Xn R62/R63)
European Association of Poisons Centres and Clinical
Effect during lactation
R64 Toxicologists
* Specific Target Organ Toxicity
New EAPCCT requirements
CLP Regulation (EC) No 1272/2008
Health hazard classes
Categories
Acute toxicity Oral
1
2
3
4
Acute toxicity Dermal
1
2
3
4
Acute toxicity Inhalation
1
2
3
4
STOT* - single exp
1
2
3
STOT* - repeated exp
1
2
Aspiration hazard
1
1ABC
2
Eye damage/irritation
1
2
Respiratory sensitisation
1
Skin sensitisation
1
Skin corrosion/irritation
Carcinogenicity
1AB
2
Mutagenicity
1AB
2
Reproductive toxicity
1AB
2
EAPCCT guidelines 2010
COMPOSITION
– Substances concentrations
Give actual concentrations of substances
in the mixture classified as:
- acute toxicity (oral, dermal, inhalation),
category 1, 2 and 3
- STOT – single/repeated exposure,
category 1 and 2
- skin corrosion, category 1A, 1B and 1C
- serious eye damage, category 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%
European Association of Poisons Centres and Clinical Toxicologists
Effect during lactation
* Specific Target Organ Toxicity
Composition
Reformulation
EAPCCT guidelines 2010
COMPOSITION – Reformulation
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
Substance 1
Substance 2
Substance
OUT
IN
Substance
- the deletion of one or more substances
Concentration:
- change to other concentration bands
3-10%
10-20%
20%
23%
- change of exact concentration above specified limit
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
European Association of Poisons Centres and Clinical Toxicologists
Categorisation
EAPCCT guidelines 2010
CATEGORISATION
- Chemical products
- Cleaning products
- Dishwasher detergents
- 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
European Association of Poisons Centres and Clinical Toxicologists
Classification
EAPCCT guidelines 2010
CLASSIFICATION
- Classification
As provided on the SDS - Section 2.1
- Label elements
As provided on the SDS - Section 2.2
H300: Fatal if swallowed
Danger
GHS05
T/T+
C
P310: Immediately call a
POISON CENTER
or doctor/physician
GHS08
GHS06
Warning
Xn/Xi
European Association of Poisons Centres and Clinical Toxicologists
GHS07
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’
European Association of Poisons Centres and Clinical Toxicologists
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.
European Association of Poisons Centres and Clinical Toxicologists
Toxicology
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
European Association of Poisons Centres and Clinical Toxicologists
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:
•
•
•
•
Evaluation of non-human information
Evaluation of human information
Classification and Labelling
Derivation of DNELs
Exposure assessment:
• Exposure scenario(s)
• Exposure estimation
Information in SDS
SECTION 11 + Annex
European Association of Poisons Centres and Clinical Toxicologists
Toxicological information
on the REACH SDS
New Annex II: effective from June 2015
European Association of Poisons Centres and Clinical Toxicologists
Toxicological information
on the REACH SDS
11
This section primarily for: medical professionals, toxicologists...
Information consistent with that provided in the registration and CSR
11.1 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
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
STOT-single exposure
STOT-repeated exposure
Aspiration hazard
European Association of Poisons Centres and Clinical Toxicologists
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
11.1.10
If a mixture has not been tested for its health effects as a whole, relevant
information on relevant substances shall be provided
11.1.11.1 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
11.1.11.2 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
European Association of Poisons Centres and Clinical Toxicologists
Other information
EAPCCT guidelines 2010
OTHER INFORMATION
Date of first marketing
Date product information form completed
Remarks
Product information form complete?
European Association of Poisons Centres and Clinical Toxicologists
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
European Association of Poisons Centres and Clinical Toxicologists
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
European Association of Poisons Centres and Clinical Toxicologists
Draft EAPCCT guidelines 2010
Summary
CLASSIFICATION
- Classification
- Label Elements
SDS
PACKAGING
- Type(s)
- Size(s)
- Labels
PHYSICAL/CHEMICAL CHARACTERISTICS
- Physical state
- pH
-Total reserve acidity/alkalinity (If available).
SDS
TOXICOLOGY
Supplied on the SDS and expected to improve with
future requirements from the REACH Regulation
SDS
OTHER INFORMATION
- Date of first marketing.
- Date product information form completed.
- Remarks
European Association of Poisons Centres and Clinical Toxicologists
Thank you for your attention!
European Association of Poisons Centres and Clinical Toxicologists