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ISSN N° 1830-6993 September 2007 1st Annual Nanotechnology Safety for Success Dialogue: the Food, Consumer, and Health Policy Perspective”, Hotel Sofitel Brussels Europe, Brussels, 25th & 26th October 2007 Following the successful Finnish Presidency Conference on “Nanotechnologies - Safety for Success” last year, DG Heatlth and Consumer Protection (SANCO) has decided to host regular annual stakeholder dialogue in its areas of competences on sustained development of nanotechnologies. The first annual dialogue will take place on 25-26 October 2007 in Brussels. The purpose of this event is to stimulate exchange of views between key stakeholders. This high-level, by invitation, dialogue workshop, also intends to exchange information on the state-of-the art with regards to applications of nanoscience and nanotechnologies to food, consumer products and health, map the interests and concerns of stakeholders and lay the foundation of a safety road map. Upcoming Events In this Issue Upcoming Events p. 1 The Scientific Committees p. 2 Recently Adopted Opinions p. 3-4-5 Ongoing Work p. 6 New Mandates p. 7 Public Consultations-Calls for information p. 8 Follow-up of adopted opinions and News p. 9 3rd Meeting of Chairs of Commission and Agency Scientific Committees/ Panels involved in Risk Assessment The third annual meeting of Chairs will be hosted by European Centre for Disease Prevention and Control (ECDC) in Stockholm on 6th - 7th November 2007. The event aims at developing cooperation and joint actions on risk assessment. It also provides an opportunity to design a common framework for risk assessment, to build up a common approach, including the general principles for RA across sectors and to built a framework for the EU and international co-operation (e.g. on procedures, confidentiality, exchange of data and information; co-operation for comprehensive (multi-source) risk assessment, etc.). More info: http://ec.europa.eu/health/ph_risk/events_risk_en.htm http://ec.europa.eu/health/ph_risk/committees/ev_20051207_en.htm http://ec.europa.eu/health/ph_risk/committees/ev_20061024_en.htm The Health and Consumer Protection Directorate General (DG SANCO) has designed a Stakeholder Dialogue Proce- dure as a follow-up to the discussion held at the Risk Assessment Days on 22nd March 2007. This modus operandi is intended to facilitate structured dialogue between stakeholders and the three Scientific Committees (SCCP, SCHER and SCENIHR). DG SANCO intends to apply this procedure on a pilot basis, initially for one year, starting on 15 Sep- tember 2007, and to monitor its functioning with view to establishing, at a later stage, a permanent procedure to be formally integrated into the rules of the Committees. Stakeholders are invited to take note of this procedure and follow the guidance provided when they wish to be in- volved in the scientific consultation process of the above-mentioned committees. For any information or comments on this procedure, please write to sanco-c7-stakeholders’at’ec.europa.eu Follow-up to the Risk Assessment Days 22 March 07

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Page 1: NewSletter of the EuropeaN CommISSIoN ScIeNtIfIc …ec.europa.eu/health/archive/ph_risk/news/newsletters/...Hotel Sofitel Brussels Europe, Brussels, 25th & 26th October 2007 Following

ISSN N° 1830-6993 September 2007

Newsletter of the European Commission Scientific Committees

“1st Annual Nanotechnology Safety for Success Dialogue: the Food, Consumer, and Health Policy Perspective”,

Hotel Sofitel Brussels Europe, Brussels, 25th & 26th October 2007Following the successful Finnish Presidency Conference on “Nanotechnologies - Safety for Success” last year, DG Heatlth and Consumer Protection (SANCO) has decided to host regular annual stakeholder dialogue in its areas of competences on sustained development of nanotechnologies. The first annual dialogue will take place on 25-26 October 2007 in Brussels. The purpose of this event is to stimulate exchange of views between key stakeholders. This high-level, by invitation, dialogue workshop, also intends to exchange information on the state-of-the art with regards to applications of nanoscience and nanotechnologies to food, consumer products and health, map the interests and concerns of stakeholders and lay the foundation of a safety road map.

Upcoming Events

In this IssueUpcoming Events p. 1The Scientific Committees p. 2Recently Adopted Opinions p. 3-4-5

Ongoing Work p. 6New Mandates p. 7Public Consultations-Calls for information p. 8Follow-up of adopted opinions and News p. 9

3rd Meeting of Chairs of Commission and Agency Scientific Committees/Panels involved in Risk Assessment

The third annual meeting of Chairs will be hosted by European Centre for Disease Prevention and Control (ECDC) in Stockholm on 6th - 7th November 2007. The event aims at developing cooperation and joint actions on risk assessment. It also provides an opportunity to design a common framework for risk assessment, to build up a common approach, including the general principles for RA across sectors and to built a framework for the EU and international co-operation (e.g. on procedures, confidentiality, exchange of data and information; co-operation for comprehensive (multi-source) risk assessment, etc.).More info: http://ec.europa.eu/health/ph_risk/events_risk_en.htm http://ec.europa.eu/health/ph_risk/committees/ev_20051207_en.htmhttp://ec.europa.eu/health/ph_risk/committees/ev_20061024_en.htm

The Health and Consumer Protection Directorate General (DG SANCO) has designed a Stakeholder Dialogue Proce-dure as a follow-up to the discussion held at the Risk Assessment Days on 22nd March 2007. This modus operandi is intended to facilitate structured dialogue between stakeholders and the three Scientific Committees (SCCP, SCHER and SCENIHR). DG SANCO intends to apply this procedure on a pilot basis, initially for one year, starting on 15 Sep-tember 2007, and to monitor its functioning with view to establishing, at a later stage, a permanent procedure to be formally integrated into the rules of the Committees.Stakeholders are invited to take note of this procedure and follow the guidance provided when they wish to be in-volved in the scientific consultation process of the above-mentioned committees. For any information or comments on this procedure, please write to sanco-c7-stakeholders’at’ec.europa.eu

Follow-up to the Risk Assessment Days 22 March 07

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?

�http://ec.europa.eu/health/ph_risk/risk_en.htm

The Scientific CommitteesFinding Information about the SCs:

By surfing on:

http://ec.europa.eu/health/ph_risk/risk_en.htm

Under the section SCs: Consultation mandates (questions)Draft agenda of the Plenary meetingsMinutes of the Plenary meetingsOpinions adoptedRules of procedureMembers

Under the section “Popularizing Risk Assessment Re-sults”

Versions of selected scientific opinions of particular inter-est for policy makers, stakeholder and the public pre-sented in a language accessible to non experts (layman language summary versions)

Under the section “News”The newsletter of the European Commission Scientific Committees, published three times a year in January, May and September. Public consultations on certain opinions before their finalisation, as well as calls for submission of dataNews about developments and events related to the work of the Committees as well as relevant risk assessment issues

By sending an e-mail:

SCCP sanco-Sc6-secretariat’at’ec.europa.eu

SCHER: sanco-Sc8-secretariat’at’ec.europa.eu

SCENIHR: sanco-Sc1-secretariat’at’ec.europa.eu

By registering to this Newsletter (free)

e-mail: sanco-c7-newsletter’at’ec.europa.eu

By registering to the Scientific Committees Alerts (free). The Alerts will be sent to inform you on new opinions published, new public consultations and mandatese-mail: jan.muyldermans’at’ec.europa.eu

Scientific advice plays a key role in the EU decision making process and for many years, EU Institutions have been advised on health, safety and environmen-tal risks by independent scientists. The Commission is committed to base its proposals and its decision on the best available scientific knowledge.

The Committees also draw the Commission’s attention to new or emerging problems which may represent an actual or potential threat.

Henceforth, a comprehensive scientific advice structure is in place, with several external agencies and three independent Scientific Committees (SCs), SCCP, SCHER and SCENIHR, advising on health safety and environ-mental risks in non-food related areas. The three Scientific Committees are based on three prin-ciples:

Excellence, independence and transparency

The Scientific Committee on Consumer Products (SCCP.) is systematically consulted on the safety of cosmetics under the Cosmetics Directive and other consumer products such as toys, sun beds etc).

The Scientific Committee on Health and Environmental Risks (SCHER) provides advice on risk assessment of chemicals, health and environment issues like effects of atmospheric pollution, indoor air quality on the health, etc.

The Scientific Committee on Emerging and Newly Identfied Health Risks (SCENIHR) cov-ers broad multidisciplinary issues and examines new issues like potential risks electromagnetic fields, of nano-technology.

The area of responsibilities are:

Introduction

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Recently Adopted Opinions

As you may know, in the Annexes to Council Directive 76/768/EEC on cosmetic products, you find the list of banned, restricted or allowed sub-stances for use in cosmetic products. In order to include substances in the annexes, the SCCP has to be consulted. The Committee then carries out risk assessments based on safety data available in the public domain or provided by industry.

Hair Dyes

In 2001, a scientific report mentioning the possible link between permanent hair dyes and bladder cancer prompted the European Commission to carry out a sys-tematic review of hair dye substances used in Europe in order to establish a positive list of these substances. In the context of the ongoing evaluation of safety dossiers submitted under this ‘Hair Dye Strategy’, the following opinions have recently been issued:

A79,1,3-bis-(2,4-diaminophenoxy)propane The use of 1,3-bis-(2,4-Diaminophenoxy)propane, and its tetrahydrochloride, as a oxidative and as a non-oxi-dative hair dye at a maximum concentration of 1.8 % (calculated as tetrahydrochloride salt, corresponding to 1.2 % of the free base) on the head does not pose a risk to the health of the consumer. Beyond the existing allergenic warning, no further restrictions are deemed necessary. More info:http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_105.pdf. B31, HC Red n° 13The information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an in vitro percutaneous absorption study should be performed in accordance with its Notes of Guidance. More info: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_104.pdf

B70, 4-Nitrophenyl aminoethylurea The information submitted is insufficient to allow a final risk assessment to be carried out. An additional muta-

genicity / genotoxicity test should be performed in order to exclude its gene mutation potential. Its stability in the presence of hydrogen peroxide should be demonstrated.More info: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_103.pdf

B72, 2-Hydroxyethyl picramic acid The information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, the possible genotoxic potential must be excluded. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The CMR classification was based on the assessment by BgVV (1993) on testes atrophy in the 450 mg/kg bw/day dose group of the 28-day study. However, more recent studies on reproduction toxicity do not support this classification. More info:http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_102.pdf

B81, HC Yellow n°10The use of HC Yellow n°10 as a semi-permanent hair dye at an on-head concentration of maximum 0.1% does not pose a risk to the health of the consumer. HC Yellow n° 10 is a secondary amine. It should not be used in combination with nitrosating substances. The nitrosa-mine content should be < 50 ppb. More info:http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_101.pdf

The Cosmetics Directive contains provisions to phase out toxicological testing of cosmetics on animals. The SCCP has summarised the advances and the current situation in the field of alternative methods since its last review in 2002. Special focus is given on the applicability of these methods for assessment of cosmetic ingredients in order to update the SCCP Notes of Guidance, which give advice on adequate toxicological testing of cosmetic ingredients.

Memorandum on Actual Status of Alternative Methods on the Use of Experimental Animals in the Safety Assessment of Cosmetic Ingredients in the European UnionThe actual status of alternative methods, suitable for cosmetic hazard testing is as follows:for 4 endpoints (skin corrosivity/irritation, dermal absorption, mutagenicity/ genotoxicity, phototoxicity) validated replacement alternatives exist;for 2 endpoints (acute toxicity, skin sensitisation) vali-dated reduction/refinement alternatives are available;for 5 endpoints (eye irritation, repeated dose toxicity, carcinogenicity, reproductive toxicity, toxicokinetics), no validated alternative methods are yet available.http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_s_06.pdf

SCCP

Dr. Ian White, Chair

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Recently Adopted Opinions

The Committee has a very broad mandate. Its deals with questions concerning the toxicity of chemicals, biochemical and biological compounds that may have harmful consequences for human health and the environment. In the context of the ongoing evaluation of the risk assessment (RA) re-ports submitted to the SCHER for peer review, the following opinions have recently been adopted:

Non surfactant Organic Ingredients and Zeolite-

based Detergents

DG Enterprise asked an opinion on the RPA report on non surfactant organic ingredients and zeolite-based detergents. As a general comment, it is opinion of the SCHER that the overall quality of the report is good and that it could represent a suitable basis of information and most of the assumptions used are acceptable. How-ever, there are some specific points that would require some more detailed comments. The SCHER also high-lighted that the level of eutrophication of most European water bodies is not so extreme and the benefits of P re-duction can be evident, although highly variable among water bodies, river basins and regions. On the health and environmental risks of co-builders in detergents for-mulations, the SCHER does not consider the present use levels of these substances as a risk to human health, but some additional information must be provided for a conclusive assessment on possible environmental risks. The adopted opinion is available on the following web-site:http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_057.pdf

European Committee for Standardisation (CEN)’s response to the opinion of the CSTEE on the assess-ment of CEN report on the risk assessment of or-

ganic chemicals in toys

The SCHER has carefully considered the written CEN response to a previous Scientific Committee for Toxic-ity, Ecotoxicity and Environment opinion (CSTEE) and has reached the conclusion that there is still insufficient information to justify the health significance of the limit

values as listed by CEN. Consequently the SCHER con-sidered that no rationale for deriving the proposed stan-dards has been provided so, like the CSTEE it is not in a position to evaluate whether the standards on organic chemicals proposed by CEN have been set on a scientifi-cally defendable basis. The adopted opinion is available on the following web-site:http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_056.pdf

Risk assessment on indoor air quality

In its opinion on risk assessment on indoor air quality, adopted on 29 May 2007 after public consultation, the SCHER recommends using the basic risk assessment procedure for toxicological risk assessment and, where possible, the margin of safety/exposure should be de-fined. It identifies data requirements and gaps in knowl-edge on human exposure to pollutants, health effects and the impact of indoor air quality on vulnerable groups of the population.

The SCHER considers that the risk assessment which takes into account the combined exposure and cumula-tive effects of the pollutants in indoor environment is seldom possible due to lack of relevant data. Association of adverse health effects with dampness, water damage and mould in buildings is potentially a serious indoor air problem and more research is needed to understand the associations to health effects.

Moreover, the SCHER concludes that, some of the stan-dards developed for ambient air measurements can be applied for the indoor environment. It does not see the development of new measurement standards as a high priority and recommends the validation and harmoniza-tion of the existing ones.The adopted opinion is available on the following web-site:http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_055.pdf

SCHER

Prof.Helmut Greim, Chair

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Recently Adopted Opinions

This Committee deals with questions related to emerging or newly identified risks related to e.g. interaction of risk factors, synergic effects, cu-mulative effects, antimicrobial resistance, new technologies such as nanotechnologies; medical devices including those incorporating substances of animal and/or human origin, tissue engineer-ing, blood products, fertility reduction, cancer of endocrine organs; physical hazards such as noise and electromagnetic fields (from mobile phones,

transmitters and electronically controlled home environments), and methodologies for assessing new risks (including interaction of risk factors, synergic and cumulative effects). In particular, the SCENIHR issues opinions on scientific and technical questions relating to Com-munity legislation on medical materials and equip-ment, which were previously dealt with by the former Scientific Committee on Medicinal Products and Medical Devices (SCMPMD).

The appropriateness of the risk assessment meth-odology in accordance with the Technical Guidance Documents for new and existing substances for as-

sessing the risks of nanomaterials

The SCENIHR opinion, adopted on 21-22 June 2007 after public consultation , concludes - in a manner which is consistent with the earlier SCENIHR opinion of March 2006 - that modifications for the existing guidance would be necessary and the risk assessment of nanopar-ticles should be carried out on a case by case basis. The SCENIHR identifies issues requiring improvements in the technical guidance and methodologies, and proposes a staged strategy for the risk assessment of nanomateri-als.

The SCENIHR examined the existing base of scientific knowledge and recognised that this subject is new and rapidly developing. The Technical Guidance Documents currently make very little reference to substances in particulate form. With respect to human health, the cur-rent methodologies described in the Technical Guidance Documents are generally likely to be able to identify the hazards associated with the use of nanoparticles. For the determination of dose – response relation-ships, special attention should be given to the expres-sion of the metrics of the nanoparticle dose since mass concentration is not necessarily the best description of dose for these materials and number concentration and surface area are likely to be more appropriate. Not all nanoparticle formulations have been found to induce a more pronounced toxicity than the bulk formulations of the same substance. This suggests that the evaluation of nanoparticle formulations should be carried out on a case by case basis. Moreover, it is important that it is determined whether test procedures will be predictive

for human health hazards for all types of nanoparticles.

With respect to environmental exposure, the validity and appropriateness of existing technologies are not always clear. In the absence of sufficient data on the fate and effect of nanoparticles on the environment, it is neither feasible nor appropriate to propose firm rules on how substances in nanoparticle form should be evalu-ated. Instead, the applicability of existing methods for risk assessment of nanoparticles should be examined. A series of recommendations for improved methodologies and areas urgently requiring additional data and scien-tific knowledge are presented. They include observations on the applicability of in vitro test procedures, QSAR approaches to nanoparticles, the prediction of envi-ronmental concentrations as well as the need for new ecotoxicity tests and the assessment of bioavailability. With respect to the performance of the risk assessment of nanomaterials, it is recommended that a staged, or tiered, approach is adopted in order to identify differ-ent adverse effects and different exposure data with nanoparticles. It is suggested that due consideration be given to the possibilities now emerging that trans-location of nanoparticles away from the portal of entry may occur in humans and other species, and that the possible passage of nanoparticles across membranes could give rise to adverse effects, for example within the cardiovascular system or following passage across the blood-brain barrier.The adopted opinion will be made available on the fol-lowing website: http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_opinions_en.htm.

Prof. James Bridges, Chair

SCENIHR

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Ongoing Work

SCHERThe SCHER has been asked to assess the

health risks of the following

Regulation 793/93 – Existing substances Zinc and its compounds (ENV) EPTAC and CHPTAC (CAS 3033-77-0 and 3327-22-8; HH) 2,2-bis(chloromethyl) trimethylene bis(bis(2-chlo-roethyl) phosphate) (V6- CAS 38051-10-4; ENV) Tris (2-chloro-1-methylethyl) phosphate (TCPP; CAS 13674-84-5; ENV) Tris [2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP; CAS 13674-87-8; ENV) Mandate:http://ec.europa.eu/health/ph_risk/committees/04_scher/scher_questionq_en.htm

The environmental risks and indirect health effects of mercury in dental amalgamMandate: http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_q_050.pdf

“Model implementation and Quantification of the Eutrophication Risk associated to the use of phos-phates in detergentsMandate:http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_q_047.pdf

SCCP

Hair DyesEvaluation of 69 substances used as hair dyes. This work takes place in the framework of the European Commis-sion’s assessement strategy for hair dye safety.

FragrancesTreemoss/Oakmoss

The fragrance ingredients treemoss and oakmoss extract have a well recognised potential to cause allergic reac-tions which has been attributed to the constituents atra-nol and chloratranol. The SCCP has been asked to assess the safety of atranol/chloratranol depleted qualities of these plant extracts in cosmetic products.More info: http://ec.europa.eu/health/ph_risk/commit-tees/04_sccp/docs/sccp_q_159.pdf

Other Substances

Tea Tree OilThe SCCP was requested to assess the safety of use of Tea Tree oil in cosmetic products and as undiluted prepa-ration.More info: http://ec.europa.eu/health/ph_risk/commit-tees/04_sccp/docs/sccp_q_172.pdf

Hydrogen PeroxideThe SCCP has been asked to assess the possible health risks associated with the use of hydrogenperoxide in oral hygiene products, taking into accont different product types, concentrations and conditions of use.

The SCCP has been asked to assess the health risks of the following

substances when used in cosmetic products:

SCENIHR The SCENIHR has been asked to assess the following:

Scientific aspects of the existing and proposed definitions relating to products of nanoscience and

nanotechnologiesThe SCENIHR is requested to make a scientific re-view of the strengths and weaknesses of existing and proposed definitions relating to nanosciences and to identify minimum set of essential criteria for definitions relating to products of nanoscience and nanotechnolo-gies. Mandate:http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_q_010.pdf The safety of dental amalgam and alternative den-

tal restoration materials for patients and usersThe SCENIHR is requested to evaluate the health effects and safety of dental amalgam and its alternatives pos-sibly by the end of 2007.

Mandate:http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_q_009.pdf

Potential health risks of exposure to noise from personal music players and mobile phones includ-

ing a music playing functionInter alia, the SCENIHR is asked to assess whether the exposure to noise from devices like personal music players and mobile phones with this function, at levels corresponding to current permissible noise emissions may cause quantifiable health risks.Mandate:http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_q_011.pdf

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New Mandates

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SCCP

Hair DyesRe-evaluation of six hair dye substances after submission of additional studies the SCCP had requested in order to complete the safety assessment.

PolidocanolPolidocanol (laureth-9) is a polyethylene glycol ether of Lauryl alcohol. The substance is used in rinse-off prod-ucts as a non-ionic emulsifier and co-surfactant, particu-larly in shampoos and hair conditioners in concentrations from 1-4%. It is also used in leave-on products such as body and face creams up to a concentration of 3%. The SCCP has been requested to assess the safety of this substance when used at the given concentrations in cosmetic products.http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_q_175.pdf

Fragrances Citral, Farnesol and PhenylacetaldehydThe SCCP is requested to review a safety assessment of these three substances performed by applying the newly developed ‘Dermal Sensitisation Quantitative Risk As-sessment’ approach. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_q_173.pdf

The SCCP has been asked to assess the health risks of the following substances

SCHERThe SCHER has been asked to assess the

health risks of the following

Antimicrobial resistance of four substances used as AMT (joint request to SCENIHR and SCHER)

The Commission has prepared a draft Regulation imple-menting measure to allow the use of four specified sub-stances (chlorine dioxide, trisodium phosphate, acidified sodium chlorite and peroxyacids) for the removal of sur-face contamination of poultry carcasses. The SCENIHR has been requested to assess the antibiotic resistance effects of biocides (see below). Furthermore, EFSA has initiated a self-tasking project on antimicrobial resis-tance. To perform an assessment of the impact on the environment and the possible emergence of antimicrobial resistance in the micro-organisms, the SCHER has been asked to assess the possible environmental impact of the four substances when used to remove microbial surface contamination from poultry carcasses.

Genotoxicity - RA methodologies approachesSeveral approaches are in use to assess the risk of sub-stances that are both genotoxic and carcinogenic. The SCHER, in consultation with the SCCP and SCENIHR was asked to give an opinion on methodologies in use and a harmonized approach for risk assessment of substances that are both genotoxic and carcinogenic in the context of the fields of competence of the three non-food scien-tific committees(Links not available yet)

SCENIHR The SCENIHR has been asked to assess the following:

Antimicrobial resistance of four substances used as AMT (joint request to SCENIHR and SCHER)

The Commission has prepared a draft Regulation imple-menting measure to allow the use of four specified sub-stances (chlorine dioxide, trisodium phosphate, acidified sodium chlorite and peroxyacids) for the removal of surface contamination of poultry carcasses. The SCENIHR has been requested to assess the antibi-otic resistance effects of biocides (see below). Further-more, EFSA has initiated a self-tasking project on anti-microbial resistance. To perform an assessment of the impact on the environment and the possible emergence of antimicrobial resistance in the micro-organisms, the SCENIHR is requested, in collaboration with EFSA, EMEA and the CRL, to assess the possible effect on the emergence of antimicrobial resistance in case chlorine dioxide, acidified sodium chloride, trisodium phosphate and peroxyacids were applied according to the proposed

conditions of use as a substance to remove microbial surface contamination from poultry carcasses.

Antibiotic Resistance Effects of BiocidesThe SCENIHR has received a request on the assessment of the antibiotic resistance effects of biocides. In light of recent scientific evidence, clarification is sought as to whether cross resistance to antibiotics should be an additional criterion to consider in the common principles for the evaluation of dossiers for biocidal products as laid out in Annex VI of the Directive (98/8/EC) of the European Parliament and of the Council on the placing of biocidal products on the market.

(Links not yet available)

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Public Consultations Calls for Information

SCCP

Safety of nanomaterials in cosmetic products The report provides a review of the applicability of currently available risk assessment methods to nanomaterials in cosmetic products, recommends a general approach the in order to assess the health risks of nanomaterials in cosmetic products and identifies data and methodological gaps where further research and development is needed. http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_cons_04_en.htm

Public consultation on Sensitivity to hair dyes -Consumer self testing The report concludes that, although the consumer self test as recommended by manufacturers might be able to detect some existing sensitivity to hair dyes, there may be potential health risks for sensitive and non sensitive consumers who conduct them. Lack of standardised methodologies and large variations in the recommended test procedures may give false-negative results to sensitive consumers. Moreover, due to the use of undiluted hair dye products on the skin and the extended exposure times, there is a risk that some consumers may develop sensitivity (skin allergy) to the hair dye substances when they conduct these self tests.http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_cons_05_en.htm

The SCCP has adopted two preliminary reports for public consultation on 19 June 2007

The call for information on “The environmental risks and indirect health effects of mercury in dental amalgam” was closed on 4 June. 23 contrib-utors sent 54 documents related to the issue.

SCHER

SCENIHR

The call for information on “The safety of dental amal-gam and alternative dental restoration materials for patients and users” closed on 4 June. 25 contributors sent 139 documents related to health effects of dental amalgam and alternatives.

Opinions approved for public consultation (SCENIHR Plenary, 21-22 June 2007):

Health Effects of Smokeless Tobacco ProductsThe report addresses health effects and addiction po-tential related to the use of STP and examines their role in smoking initiation and cessation. Furthermore, the possibility to extrapolate the experience and use pat-terns from countries permitting the marketing of oral tobacco to other EU-countries where it is currently not available was assessed.http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_cons_06_en.htm

The safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates

and other groups possibly at riskThe preliminary report was approved for public con-sultation on 21-22 June 2007 pending the administra-tive process with data submitters. The consultation is expected to start in September See http://ec.europa.eu/health/ph_consultations/con-sultations_en.htm

EMF meeting 13-14 June 2007

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Follow-up of adoped opinions - News

SCHER

SCCPPresentation of SCCP opinion in conferences and meetings onUV radiation and sun beds

The SCCP adopted an opinion on “Biological effects of ultraviolet radiation relevant to health with particular reference to sunbeds for cosmetic purposes” in June 2006.The Low Voltage Directive (LVD) Administrative Co-operation Working Group (an independent Working Group run by Member States) agreed that the recommendations made by the SCCP, including the irradiance limit of 11 SED/h (0.3 W/m2), should be implemented in Member states from 23 July 2007 (LVD-ADCO Declaration of 14 November 2006). From this date, the manufacturing and sale of sun beds with a higher irradiation is prohibited

Indoor air risk assessmentSCHER conclusions and recommenda-tions will involve follow up by both the DG SANCO services concerned other Commission services. Research Recom-mendation are included in the 7Frame-work Programme

The opinion will be used as basic docu-ment by the expert working group on indoor air quality which provides a forum for exchange of best practice and information, and advice the Commission on EU programmes and polices related to indoor air quality.

SCENIHREMF

The Commission has set up a Working Working Group with Member States Rep-resentatives for the Implementation of Council Recommendation 1999/519/EC on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz). The first meeting was held 13-14 June 2007 and the question-naire on the implementation situation was sent to the Member States was sent out in early July.

The Second meeting of the Working Group with Mem-ber States Representatives on the Implementation of Council Recommendation 1999/519/EC on the limita-tion of exposure of the general public to electromag-netic fields (0 Hz to 300 GHz) will be held in November 2007.

Meeting of the Discussion Group on Emerging Risks, Brussels, 20 September 2007

Following the Second Meeting of Chairs of EU risk assess-ment bodies of 24-25 October 2006, a working paper was drafted to present an analysis of current practice to detect and assess emerging risks and opportunities for coopera-tion between the Commission and different Community bodies and institutions competent on this issue. This paper aims to summarize the main outcome on emerging issues from the 2nd Meeting of Chairs, identify current activities of different Community bodies, and highlight priority areas on which joint activities could be started. Based on this draft, the group will discuss the next steps to achieve the following potential medium-term goals: to identify all bod-ies (organizations) operating at a European or international level as possible partners of a European undertaking, to propose guidelines and actions which could be undertaken to establish a co-operative Community system for handling emerging risks and to clarify respective roles of differ-ent bodies participating in the above-mentioned European undertaking.

Meeting on Building Risk Assessment Capacity in Eu-rope – Supply and training of risk assessors

Scientists participating in the Commission scientific adviso-ry bodies have voiced their concern of what seems to be a short supply of trained risk assessors. In order to explore particular needs in the area of risk assessment training and supply as well as to possibly identify initiatives and the lev-els of appropriate action to remedy the situation, the Com-mission will host a first informal brainstorming meeting on the 20 of November 2007. Participants will include the Chairs and Vice-Chairs of the three Scientific Committees, experts from academia, scientific organisations, industry, and national authorities.

Lay language summaries / Bringing the results of the Scientific Committees closer to the public

The SCCP, the SCHER and the SCENIHR provide the Com-mission with the sound scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. These opinions fre-quently address issues of concern to stakeholders, policy makers and the general public. Non-specialists often have difficulties to comprehend the technical language. That is why the Commission has launched a project providing summaries of the most rel-evant scientific opinions in a format and language which can be easily understood by non-specialists.The summaries of the scientific opinions on the safety of tooth whiteners, sunbeds and nanotechnology are now available on the SANCO webpage:http://ec.europa.eu/health/ph_risk/popularizing/popular-izing_results_en.htm