1SH Platform Oct 2007, SC activities

EFSA’s Scientific Committee Activities relevantto cloning, nanotechnology

and transparencyJuliane Kleiner, EFSA

Team Leader Scientific Committee

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Nanotechnology

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Nanotechnology -Background

• Since 2006 EFSA is following developments of nanotechnology in the area of its remit

• Internal working group set up which prepared an internal report giving a synopsis of current knowledge, trends and developments in the food and feed area.

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Nanotechnology – draft mandate

• Original mandate by the European Commission received on 29 June 2007 and related to the risks arising from nanotechnologies on food and feed safety

• Draft mandate was discussed at SC Plenary meeting in July and Sept. and considered as too broad as

– not possible to conduct a generic risk assessment as it depends on physical and chemical properties and toxicokinetic of nanomaterial in question

– at present not feasible to scientifically assess the relative magnitude of the hazards associated with actual/foreseen applications

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Nanotechnology - revised mandate

Poposed revised mandate sent to EC on 12 October 2007EFSA to produce an initial scientific opinion on the need for specific risk assessment approaches of applications of nanotechnology in the food an feed areaOpinion to identify nature of possible hazards associated with actual/foreseeable applicationsMember States to be involved to learn from their experience and to ensure harmonised approachesAlready generated opinions by EU scientific advisory bodies, and third countries to serve as a basis

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Nanotechnology - process

• EFSA currently asking Member States to propose leading scientific experts by 2 Nov. 07

• Working group (10-15 experts) to be established including members of SC and relevant Panel members and outside experts to prepare opinion

• Opinion to be available by summer 2008

• Point-counter-point discussion on nanotechnology in Food at EFSA’s Scientific Forum, 20-21 Nov.2007

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Nanotechnology – questions received• EFSA was asked to evaluate the safety of a

silicon dioxide coating in situ on the inner surface of PET articles. The coating is intended to provide gas barrier properties and the max thickness is 100 nm. EFSA opinion published in Feb. 2007

– Only to be used as surface treatment agent on PET• Recent request for a safety evaluation for a

titanium nitride based nanoparticle to be used as a food contact material additive

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Animal Cloning

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Animal Cloning - Mandate

The European Commission requested EFSA to advice on food safety, animal health, animal welfare and environmental implications of life cloned animals obtained through somatic cell nuclear transfer (SCNT) technique, their offspring and of the products obtained from those animals

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Animal Cloning - Timetable

• Request by EC received April 2007• Acceptance of mandate and timeframe after discussion

with EFSA Scientific Committee (April 2007)• Request for scientific data (May-Sept 07)• WG established under the aegis of the SC• 4 WG meetings and several conference calls held to

prepare draft scientific opinion • SC meetings to discuss and endorse draft opinion for

public consultation in Sept and Nov. 2007• Public consultation foreseen for Dec 07 –Jan 08

including a dedicated stakeholder meeting• Adoption of scientific opinion foreseen in Feb. 08

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Aninmal Cloning - Working group

• Working group composed of 14 experts covering the following areas:- animal reproduction technology- genetic characterisation- animal health- animal welfare- toxicology

• All Declarations of interest have been carefully screened for any possible conflict of interest

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Animal Cloning – Issues to be addressed

• Animal reproductive techniques, cloning and definitions• Consideration on appropriate comparator• Epigenetics and genetic aspects of SCNT• Animal health implications for clones and offspring• Animal welfare aspects for clones and offspring• Safety of meat and milk from clones and offspring• Impact on environment and genetic diversity

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Animal Cloning

• Species to be covered: mainly pigs and cattle and sheep and goats if data available

• Issues not addressed in the opinion– ethical aspects (dealt with by the

European Group on Ethics in Science– transgenic animals and cloning

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Transparency in Risk Assessment – Scientific

Aspects

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Transparency - Aim

To provide guidance to ensure confidence in the process and output of EFSA’s scientific work

Process related transparency issues http://www.efsa.europa.eu/en/science/sc_commitee/sc_documents/1494.html

Science related transparency issues

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Transparency - content

1. General introduction2. General principles for transparency in risk assessment

- Data sources, availability and quality- Criteria for inclusion/exclusion of data- Assumptions- Variabilities- Complexity- Interpretation issues

3. Specific issues in various areas of assessment- Background highlighting specifics in the risk assessment methodology

- structure according to chapter 2 4. Opinions issued by bodies other than EFSA

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Transparency - Timeframe

• Working group established: Nov. 2006• 4 Working group meetings held• Next meetings: 25 October 2007, 22-23 Jan. 08 • Possible adoption for public consultation at SC Plenary

meeting in February 2008• Public consultation March – April 2008• Dedicated stakeholder meeting: March/April 2008• Finalisation and adoption of document before summer

2008

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Thank you!