european association of poisons centres and clinical toxicologists draft eapcct guidelines review of...

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


Detailed product information necessary!

Informing the public and/or medical personnel about symptoms and treatment of acute intoxications

Poison Centres


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


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


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


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


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


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


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!


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. “


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%


Source: EAPCCT newsletter of April, 1996

Composition


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


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).


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%


Source: EAPCCT newsletter of April, 1996

Composition Substance concentrations


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


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


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


Acute toxicity Oral



STOT* - single exp


Aspiration hazard




Skin sensitisation

Carcinogenicity

Mutagenicity



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


1AB

1AB


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


Directly translating T+, T , C


Acute toxicity Oral



STOT* - single exp


Aspiration hazard




Skin sensitisation

Carcinogenicity

Mutagenicity



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



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


- 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


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


- 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


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+


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’


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


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


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


New Annex II: effective from June 2015

Toxicological information on the REACH SDS


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


Serious eye damage/irritation

Respiratory or skin sensitisation

Germ cell mutagenicity

Carcinogenicity


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



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



Date of first marketingDate product information form completedRemarks

EAPCCT guidelines 2010OTHER INFORMATION

Other information

Product information form complete?


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


- 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



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



Thank you for your attention!

european association of poisons centres and clinical toxicologists draft eapcct guidelines review of...

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mixture variants

mixture paints

detailed information

relevant mixture identifiers

mixture identifiers

harmonisation of information

toxicological information

poisons centres clp