Maristella Rubbiani

CSC/ISS Novità in materia di CLP :

impatto sui biocidi

REGULATION 1272/2008 - CLP - (REPLACED 67/548/EU DIRECTIVE) (REPLACING 99/45/EU DIRECTIVE)

CLP/

Dangerous

Preparations

REACH

Deter-

gents Aerosol

Paints Biocidal

products

Plant

protection

products

Dangerous

Substances

Professional/

non professional

products

CLP IMPACT ON:

Biocides (active substances and products)

Art 45 CLP

Active substances

Cut-off criteria

Candidate to substitution

Low risk substances

Harmonized classification (ECHA)

Products

New cut-off for mixtures (ex. irritating/reprotox)

Professional/non professional (ex. exclusion for general public of some categories)

Biocidal product family (same category of danger)

Label (RMM, specific phrases for biocides)

Sustainable Use Directive

CLP IMPACT ON BIOCIDES

CLP AND BIOCIDES

Active substances: Article 36(2) CLP “A substance that is an active substance in the meaning of … Directive 98/8/EC shall normally be subject to harmonised classification and labelling.”

Biocidal products: are mixtures and shall be classified, packaged and labelled according to CLP (see also Art 69.1, 69.2 for label requirements, 70 for SDS and 72.1 for advertising)

BIOCIDAL PRODUCTS REGULATION AND CLP

Art 69: Holders of authorisations of biocidal products must ensure that the authorised products are classified and labelled in accordance with the approved summary of biocidal product characteristics, and according to relevant pieces of CLP legislation.

Art 22: A biocidal product authorisation granted by a Member State or the Commission shall include an SPC, proposing hazard and precautionary statements.

The authorisation finally granted by a Member State or the Commission may, where justified, could impose different statements as a condition for the authorisation.

Hazard and precautionary statements on the label are part of the conditions for authorisation

Art 50: It obliges an authorisation holder to notify the CA or, ECHA, in case of changing any information submitted in relation to the initial application for authorisation.

This includes re-labelling of a product, for new scientific or technical information, or for a change in composition, or because of new regulatory requirements (1 June 2015:application CLP Regulation).

The same provision obliges the CA or Commission, to decide whether the product still fulfils the criteria for being authorised and, terms and conditions of the authorisation

Exclusion criteria (Art 5.1): CMR category 1A or 1B, vPvB,

PBT and endocrine disrupters (pending adoption criteria: CR category 2

or R category 2 and toxic effects on endocrine organs (Art 5.3))

no approval unless meeting conditions for derogation (Art 5.2)

Substitution criteria (Art 10.1): approved in accordance with Art 5 (2)

(Art 10.1.a); respiratory sensitiser (Art 10.1.b)

comparative assessment under product authorisation

Active for biocidal products eligible for simplified procedure (Art 28):

gives rise to concern if classified as … (see Art 28.2.a)

AUTHORIZATION-CLP AFFECTED BY:

BIOCIDES LABEL CHANGES Different positions on obligation to declare label changes from DPD to CLP:

UK -SE no need to notify changes which were compatible with DPD.

NO-AT- IT consider the information on the label critical for a good communication with the user.

FR agrees and proposes also to have a similar approach for other regulatory issues (e.g. composition changes).

IT consider important and necessary any notification in label changing

SE would also like to postpone the notification of these changes to the renewal of authorisations.

DE proposing the removal of this provision from the changes Regulation

CLP Regulation, remind that:

• The supplier shall ensure that the label is updated, without undue delay, following any change to the classification and labelling of that substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required.

• Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay.

• Where labelling changes are required the supplier shall ensure that the label is updated within 18 months.

• The supplier of a substance or a mixture within the scope

of Regulation 528/2013 or 1207/2009 shall update the

label in accordance with those Regulations.

WHO IS RESPONSIBLE

IN THE SUPPLY CHAIN

THE ONE PLACING THE SUBSTANCE OR MIXTURE ON THE MARKET MUST

CLASSIFY AND LABEL IN ACCORDANCE WITH DIRECTIVE 67/548 and

99/45

‘PLACING ON THE MARKET’ MEANS MAKING AVAILABLE TO THIRD

PARTIES. IMPORTATION INTO THE COMMUNITY CUSTOMS TERRITORY

SHALL BE DEEMED TO BE PLACING ON THE MARKET FOR THE PURPOSES

OF THIS DIRECTIVE

CHANGES

Hazard categories

Risk phrases(R)

Safety prahes(S)

Symbol

Hazard classes

Hazard statements(H)

Precautionary statements(P)

Pictograms

- New graphics

- New pictograms

DPD CLP

Frame

Symbol Pictogram

Color

Flammable

Application criteria differ significantly!!!!!

SOME EXAMPLES

Lower concentration limits for SKIN IRRITATION and REPROTOX

DPD CLP

SYMBOL R phrases PICTOGRAMS H statements

Xn, N

R22: harmful by

ingestion

R38: skin irritant

R40: possible

carcinogen

R50/53: Highly toxic for

aquatic organisms

GHS06 GHS08 GHS09

H301: Toxic by ingestion

H315: skin irritant

H332: Harmful by

inhalation

H400 : Highly toxic for

aquatic organisms

H410: Highly toxic for

aquatic organisms with

long lasting effects

H351: carc. cat.2

H361 fd: repr. cat.2

DANGER

SOME EXAMPLES

DPD CLP

SYMBOL R phrases PICTOGRAMS H statements

N

R50/53: : Highly toxic for

aquatic organisms

GHS05 GHS07 GHS09

H317: Can cause a

sensitizing reaction

H318: Causes serious

eye damage

H400: Highly toxic for

aquatic organisms

H410: Highly toxic for

aquatic organisms with

long lasting effects

DANGER

Lower concentration limits for SKIN IRRITATION and REPROTOX

LABELLING

Appropriate labelling requirements will be a key instruments for ensuring that substance approval and product authorisation provided will lead to acceptably safe use of authorised biocidal products:

CLP provisions

Specific phrases (analogy to PPPs)

Specific RMMs

CLP AND HARMONIZED CLASSIFICATION FOR ACTIVE SUBSTANCES New regulation BPR and the new PPP regulation provide both the non-eligibility for use (not included in all. 1) for substances classified as CMR of category 1A and 1B, PBT, vPvB, and neurotoxic (cut-off criteria)

The assessment of the classification must be conducted and prepared by the CLH in a joint with assessment for inclusion in all.1 and by the same experts who had made evaluation for DAR (PPP) / CAR (BP)

All biocides (and PPP) substances already allocated to MSs for the evaluation of inclusion in all.1 will proceed for the elaboration of a CLH dossier, also requiring IUCLID 5 annex

No fees are provided for this additional workload to MSs

TIMING

Moreover, for PPPs and BPs, to allow the public consultations and the eligibility for the harmonized classification, the CLH document must be drawn up and

handed to ECHA in conjunction with the DAR (PPPs)/CAR (BPs ) as substances could show some of the cut-off properties mentioned above, and in this case the non-eligibility would be automatically applicable.

No Biocide expert are provided in RAC Committee when evaluating C&L for these specific substances

6 ATP CLP :FORMALDEHYDE

THE SEVENTH ATP

BIOCIDES : CLP AND AVKS ACTIVES (ANTICOAGULANTS)

The proposed new classification already consolidated with new active substances SCLS for anticoagulants, is Cat 1A as a result of a read across with warfarin for reproductive toxicity.

This would lead to a classification of the product, containing nominally 0.005% of active substance, which would exclude non-professional use of these products.

Moreover, given the greater danger, some Member States would like the application of this classification immediately, without waiting for the correspondent ATP ( 9th?) implementing the RAC decision.

CONSEQUENCES

Only professional use to be sold in the appropriate shops

Applicants trying to reduce concentrations from 0.005% to 0.0025% (SCL = 0.003%)

Consequences:

New efficacy studies in progress

New cost

Composition changes

New evaluations

New fees

Resistance ?

BIOCIDES : CLP AND REPELLENTS

Relevant impact on those products containing irritating substances, depending on the concentration

Insect skin repellents :

Due to the specific mode of use, products containing irritating substances for skin in concentration equal or higher 10 % could be out of the market as they should classified as irritating for the skin.

BIOCIDES : CLP AND REPELLENTS

Skin repellents classified as eye irritating products, could be sold only according to specific application mode and with specific risk mitigation measures:

Insect skin repellent classified as:

H318 : Causes serious eye damage

H319 : Causes serious eye irritation

-may be authorized in several formulations classified as H319 but with appropriate sentences on the label

-may be authorized in roll-on formulation classified H318 always with appropriate sentences on the label

Liquid formulation / spray classified H318 cannot be authorized

CONSEQUENCES

Skin irritating products are obviosuly in conflict withe the mode of use (skin application) and no mitigation measures could be applied.

Applicants trying to reduce concentrations from 20% to <10%

Consequences:

New efficacy studies in progress

New cost

Composition changes

New evaluations

New fees

New packaging type development (more roll-on)

PRESERVATIVES

Most common used preservatives contains sensitizing substances such as:

Methyl iso-thiazolinon

Benzoiso-thiazolynon

Octabentazon

Propiconazole (fungicide)

Permethrin (insecticide)

should provide the labelling phrase « Contain……(substance) . May cause an allergic reaction» (EUH 208) applicable to concentrations ranging from 0.01%- 0.001%

Often with specific concentration limits.

Anionic surfactants:

Sodium Dioctyl-sulfo succinate

Calcium Dodicyl-benzen sulphonate

+ 2-ethylhexanol (solvent)

Phosphoric esters

Non ionic surfactants: Branched alchools, oxo-hetoxylated

Non ionic surfactants : Hetoxylated esters

H315 / H318 / H319

NOT CLASSIFIED

Solvents: Buthyldiglicole

Glicerol formal

Propilen Carbonate

Fatty acids from plant origin, methyl esters

Dipropylen glicol monomethyletere

Dimethyl adipate/glutarate/succinate

H319

NOT CLASSIFIED

CO-FORMULATING AGENTS

A better preservative action, leading to a better efficay, is often linked to negative intrinsic properties for HH and environment, leading consequently to classification due to chemical activity(eg products henancing dermal penetration or sensitizers, flammable, irritating, haspiration hazard inducers, etc).

For reaching a good emulsifier action (resulting in a better efficacy), the anionic surfactants (classified) should be now replaced by a greater quantity of non ionic surfactants.

Also irritating and flammable solvents are currently going to be replaced by not dangerous solvents such as vegetable oils (such methyl esters from plant origin, rapeseed oil), or dimethyl glutarate, dimethyl succinate, dimethyl adipate or dimethyl esters of adipic, glutaric, and succinic acids.

Among the non ionic surfactants it should be reminded that almost all the hetoxylated alchools are now classified by CLP regulation, lefting scarce possibility of using not classified mixtures as alternatives.

CO-FORMULATING AGENTS

CLP: impact on detergents

Category of Danger Concentration limit for classification

Acute oral toxicity 1* 0.025%**

Acute oral toxicity 2* 0.25%

Acute oral toxicity 3* 5%

Acute oral toxicity 4* 25%

STOT 1 1%

STOT 2 10% (but needs SDS on request at 1%)

Skin corrosion 1 5% (becomes Cat 2 skin)

Skin corrosion 1 3% (becomes Cat 1 eye)

Skin corrosion 1 1% (no classification)

Skin irritation 2 10%

Skin or respiratory sensitiser

1% (but needs SDS on request at 0.1%)

CM Cat 1a, 1b 0.1%

R Cat 1a and 1b 0.3% (but needs SDS on request at 0.1%)

CM Cat 2 1% (but needs SDS on request at 0.1%)

R Cat 2 3% (but needs SDS on request at 0.1%)

Aquatic acute 1 0.1% ****

Aquatic chronic 1 0.1% ****

Aquatic chronic 2 1%

Aquatic chronic 3 10%

Aquatic chronic 4 1 %***

* Based on ATE point estimate in Table 3.1.2, ** Note that if below limit of concern of 0.1% for Cat 1, the legal text implies that substances can be ignored unless it is known to be of concern. Rather vague ! *** Consider on case-by-case, especially if potential vPvB or PBT. **** Note M factor

Note that the text of the CLP Regulation covers this in detail and this is a summary of limited endpoints.

-DPD : 20 % -DPD : 5 %

ASSIC 18.3.2015

Different risk perception linked to new symbols, graphics

and statements:

• Needing of new training for workers, distributors and

consumers.

• New approach for professional and non professional

uses

Rising of the number of classified products:

Lower attention from consumers/workers about products

which are almost ALL classified?

CONSEQUENCES:

CLP Regulation - Article 45

Provisions in Art. 45 of CLP similar to Art. 17 DPD

– MS shall appoint body or bodies responsible for receiving

information on mixtures classified as hazardous on the basis

of their health or physical effects

– Appointed bodies shall keep information confidential

– Information may be used

•For medical purposes, in particular in event of emergency

•Where requested by MS, for statistical analysis to

improve risk management measures, if needed.

Links to other EU legislation

• Regulation on Plant Protection Products

(Regulation (EC) 1107/2009)‏

• Biocidal Product Regulation (Regulation 528

/2013 and Directive 98/8/EC)‏ • Regulation on Cosmetic Products (Regulation

(EC) 1223/2009)‏: a central European database for notification of cosmetic products is already in an advanced stage and the Cosmetic Products Notification Portal (CPNP) is working.

Info to be submitted

• Information about the composition of mixtures;

• Information on the product category;

• Information on the size and type of packaging;

• Information on whether the product is used by

consumers and / or by industrial users.

DIFFERENT IMPLEMENTATIONS WITHIN MEMBER STATES RELATED TO:

- Requirements for notification of the composition

(eg, concentration or concentration ranges)

- Format of notification

- Methods of IT transmission

- Access to information

- Purpose System

-Quality of information (eg.. only hazardous ingredients, only

non-professional products, etc.)

Harmonization possible

• Decentralised system for submitting information

• Chemical composition of mixtures

• Designation of ingredients

• Establishment of a data set version identifier (DVI)‏

• Type of information requested

• Product categorisation system (PCS)‏

• Unique company identifier (UCI)‏

• Unique product identifier (UPI)‏

“Developing the required information which allows the European

Commission to broadly estimate the positive and negative impacts of a

harmonised notification system of data to be transmitted to Poison Centres”.

for evaluating costs related to:

1. notification under the existing national notification systems;

2. notification under the planned harmonised reporting format;

3. key multiplication factors to allow a cost estimate at EU level;

4. costs and benefits (costs-savings) of obligatory provision of information

under the proposed harmonised reporting format;

5. additional costs for the unique formula identifier (UFI).

STUDY GOALS

Unique Product Identification (UPI)‏

UPI would be a useful tool for solving

Problems identified by PCs or by industry, e.g:

• to identify unambiguously the product involved in an incident;

• to determine the composition of mixtures composed of mixtures when suppliers do not

• to disclose all information to downstream users.

• to comparison of exposure data of products in certain categories between European Poisons Centres

• to better combine exposure data of European Poisons Centres into one european annual report

UNIQUE FORMULA IDENTIFIER (UFI) ©

ALPHANUMERIC CODE

4 blocks of 4 digits

xxxx-xxxx-xxxx-xxxx o EU Vat number o Company ID o Formulation ID

Generated by Free IT tool?

o

Printed on each pack o SDS for industry

EU IT projects???

COST ESTIMATION FOR UFI IMPLEMENTATION Total annual costs associated with the generation of UFI are estimated to be 81.600 Euro per company / year

(calculated as products multiplied by 340 to 240 Euro per product / submission).

Season Total: 115,200 Euro per year.

The eventual introduction of even a harmonized format in addition to the 'UFI should increase the costs.

A certain number of industries have raised concerns about the projects

relating to the proposals presented by the European Commission on the

harmonization of the information to be submitted to poison control

centers especially for the enormous amount of work expected.

The Commission may adopt an amendment to the CLP Regulation, on

the basis of a review of the possibility of harmonizing the information,

including a standard format for submitting information.

The competent authorities for REACH and CLP have discussed the issue,

and the parties concerned have been able to submit additional

observations.

SOMETHING IN PROGRESS :

TIMING

The Commission is expected to publish final proposals and could come into force at the end of 2015, meanwhile, is evaluating the impact of its plans on the possibility of:

A) introducing a standard format for the notification requirement

B) set a code (Formulation Unique Identifier, UFI) that connect a specific composition to a specific blend only on the Community market

C) Allow a transitional period (3-5 years) for adapting current systems

Due to CLP application for mixture (June 2015):

CONCLUSIONS • With the introduction of CLP to mixtures, the number of classified

preparations will increase, in some cases with heavy consequences for biocidal product classification and restrictions.

• Besides a change in hazard classification and hazard communication elements for substances and mixtures, the label, sds (REACH Regulation had improved the toxicological information present on the new SDS)and subsequently the notification to national databases of product information by companies will be amended.

• It is therefore highly likely that the impact resulting from the application of the CLP also inevitably leads to deep modification for some products and consequently new RMMs should/restrictions could apply

• Applicants, EU Member States, professional, but mostly non-professional users, have to prepare themselves to handle a substantially modified and increased quantity and quality of information on hazardous products.

Thank you for your attention maristella.rubbiani@iss.it