Novità in materia di CLP : impatto sui biocidi. Maristella Rubbiani CSC/ISS

Transcription

1 Novità in materia di CLP : impatto sui biocidi Maristella Rubbiani CSC/ISS

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

3 Professional/ non professional products Paints Biocidal products REACH CLP/ Dangerous Preparations Plant protection products Aerosol Detergents Dangerous Substances

4 CLP IMPACT ON: Biocides (active substances and products) Art 45 CLP

5 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

6 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)

7 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

8 AUTHORIZATION-CLP AFFECTED BY: 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)

9 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

10 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.

11 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

12 CHANGES DPD Hazard categories Risk phrases(r) Safety prahes(s) Symbol CLP Hazard classes Hazard statements(h) Precautionary statements(p) Pictograms - New graphics Flammable Color Frame Symbol Pictogram - New pictograms Application criteria differ significantly!!!!!

13 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 DANGER 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

14 SOME EXAMPLES Lower concentration limits for SKIN IRRITATION and REPROTOX 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

15 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

16 CLP AND HARMONIZED CLASSIFICATION FOR ACTIVE SUBSTANCES New regulation BPR and the new PPP regulation provide both the noneligibility 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

17 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

18 6 ATP CLP :FORMALDEHYDE

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20 THE SEVENTH ATP

21 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 ( 9 th?) implementing the RAC decision.

22 CONSEQUENCES Only professional use to be sold in the appropriate shops Applicants trying to reduce concentrations from 0.005% to % (SCL = 0.003%) Consequences: New efficacy studies in progress New cost Composition changes New evaluations New fees Resistance?

23 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.

24 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

25 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)

26 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% % Often with specific concentration limits.

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28 CO-FORMULATING AGENTS 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 Solvents: Buthyldiglicole Glicerol formal Propilen Carbonate Fatty acids from plant origin, methyl esters Dipropylen glicol monomethyletere Dimethyl adipate/glutarate/succinate H315 / H318 / H319 NOT CLASSIFIED H319 NOT CLASSIFIED

29 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.

30 CLP: impact on detergents

31 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 1% (but needs SDS on request at 0.1%) sensitiser 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 %

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33 CONSEQUENCES: 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?

34 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.

35 Links to other EU legislation Regulation on Plant Protection Products ( 1107/2009 (EC) (Regulation Biocidal Product Regulation (Regulation 528 ( 98/8/EC /2013 and Directive 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.

36 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.

37 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.)

38 Harmonization possible Decentralised system for submitting information Chemical composition of mixtures Designation of ingredients ( DVI ) Establishment of a data set version identifier Type of information requested ( PCS ) Product categorisation system ( UCI ) Unique company identifier ( UPI ) Unique product identifier

39 STUDY GOALS 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).

40 ( UPI ) Unique Product Identification 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

41 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???

42 COST ESTIMATION FOR UFI IMPLEMENTATION Total annual costs associated with the generation of UFI are estimated to be 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.

43 SOMETHING IN PROGRESS : 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.

44 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

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47 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 nonprofessional users, have to prepare themselves to handle a substantially modified and increased quantity and quality of information on hazardous products.

48 Thank you for your attention