Presentation on theme: "Andrej Kobe EP Brussels, 21 November 2011"— Presentation transcript:
1Andrej Kobe EP Brussels, 21 November 2011 Nanomaterials and environmental legislation “Regulatory strategies under REACH framework”Andrej KobeEP Brussels, 21 November 2011
2Content Past and curent activities Definition and its role Environmental legislationInter-dependence, data and uncertaintySome basic paradigms and their applicationSame treatment as all chemicals, case-by-case approach, read-accrossPrecautionary principleConclusions[Pivotal role of research ‘taken for granted’ in presentation]
3Key deliverables in 2011/12 2011 Definition of a nanomaterial RIPoN : REACH Implementation projects on NanomaterialsJRC (+ECHA) REACH nano-adequacy review (ongoing)Studies: Env regulatory review, Industrial emissions of NM and ultrafines20122nd regulatory review of nanomaterialsReport on nanomaterial types and uses on the market and safetyREACH reviewOther activities (ECHA, COM)
4Definition of a nanomaterial "Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm nm.In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.By derogation from point 2 (1 on this slide), fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.
5Definition – role in env legislation Based solely on size – exact scope of application will be defined for individual legislatione.g. restrict action to manufactured NM, include additional materialsPotential applicationSpecial risk assessment considerations, data generation and reporting, labelingBiocides, EcolabelAlready applied to information requirement and risk assessmentREACH/CLPECHA invited to immediately use as appropriateExtended role might require changes to REACH provisionsReview in 2014
6Environmental regulatory review Covers NM in principle, but no NM (as yet) identified as pollutantClassification under CLP often required which unlocks impl. toolsKnowledge gaps: chronic toxicity, eco-toxicity, exposureIn some cases (e.g. WFD) recognized the identification method not appropriateWith exception of (implicitly) REACH, env. legislation generates data only for specifically identified pollutantsChallenges: monitoring techniques, quantification of effectiveness of measuresInformation expectation high if to apply env. leg. RMM(e.g. emission limits, env. quality standards, separate treatment of waste)Upstream & downstream legislationDownstream much less timely and effective, if at all feasibleEnsure effective REACH/CLP implementation for NMApply in precautionary manner
7RIPoN – REACH Implementation Projects RIPoN 1 – Substance identificationTop-down solution: no consensus between stakeholders.COM: substance ID driven by data sharing, registrant responsible for management of risks for all forms under scope of registrationECHA: bottom-up development of experience.RIPoN 2 – Information requirementsRecommendations to ECHA and COM (guidance + Annexes)RIPoN 3 – Chemical Safety AssessmentRisk assessment paradigm applicable, case-by-case requiredNo new endpoints identified, but specific considerations: tests might require modification, appropriate metrics, limited alternatives to testingRead across only when scientifically justifiedRecommendations to ECHA (guidance) and researchRIPoN2&3 avoided discussion on forms as throughout related only to single (nano)form.
8NANO SUPPORT JRC (+ECHA) nano adequacy review Identification and assessment (45 dossiers)Detailed assessment (25 dossiers). Not a compliance check!Generally not possible to identify the scope of registration and/or verify whether nanomaterial and/or nanoforms were addressedLittle detailed information on characterisation of formsTypically one set of data for all forms covered by all registrantsOptions to adapt REACH + their impacts (ongoing - draft proposals)Characterisation, then specific treatment of form throughout the dossierScientifically justify read-across between formsAddress nano-specific uses and form/state of NM
9Implementing paradigms #1 NM is just another chemical, assessment case-by-caseExample: functional group vs. functionalized surfaceRIPoN1 – characterizer vs. identifier – unfinished debateIf properties differ shouldn’t the assessment be separate if all forms are to be covered?Read-acrossWell developed concept between chemicals: argumentation requiredRIPoN conclusion : for NM possible when scientifically justifiedCategorization, grouping, QSAR etc. : not yet available for NMPriority for development!Current practice and lack of provisions ‘allow’ implicit read-across by not differentiating between forms in the dossier or in communication (Safety Data Sheet).
10Implementing paradigms #2 Precautionary principleTreaty, single law (e.g. “underpins REACH”) and inter-legislationIdentification and application of most effective toolsEnsuring effectiveness (and application) of upstream regulationImproving knowledge basePromoting safety by design, addressing societal needsDeveloping tools that support implementation & enforcement
112nd Regulatory Review of nanomaterials Information on nanomaterial types and uses, including safety aspectsCommunication and associated Staff Working DocumentPrincipal inputs identified but interpretation still in internal discussionIncluding views on EU database, product registerAdoption planned in January 2012
12REACH/CLP case-by-case read-accross In conclusion Need “integrated, safe and responsible” strategyEnv legislation covers NM in principleProof in practice is still ongoingRisk assessment paradigm and most implementation tools applicable, may often require adaptationcase by case approachImportant knowledge gaps impede implementationInter-dependence between legislation: Risk & Opportunitye.g. CLP: Supports consistency but will introduce time delay and negative ripple effect when inadequate upstreamREACHMajor (the only regulatory) generator of dataAdditional ‘responsibility’ as upstream legislationFollow-up required on identified implementation issuesREACH/CLPcase-by-caseread-accross
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