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ISSN nr: 1830-6993 Catalogue nr: ND-AG-12-002 EN-N of the European Commission Scientific Committees Review of events .1
The Scientific Committees .2
Opinions Adopted .2-4
Ongoing work .5-7
Public Consultation .7
Inter CommIttee CoordIna-
tIon Group meetInG,
8 oCtober 2012
The chairs and vice chairs of the Scientific Committees met on 8 October 2012 in or-der to discuss general issues related to the Committees. Topics discussed at the meet-ing were: collaboration with other community bodies, joint opinions, horizontal activities and other general matters. Agreement was reached on the way forward on documents on Future Challenges in Risk Assessment and Making Risk Assessments more Relevant for Risk Managers. Both will be further developed as discussion documents and not as opinions. The outcome of the meeting was found to be very positive by the participants.
SCIentIfIC CommIttee expertS partICIpated In the efSa workInG Group on
Following the submission of a mandate the Commission's Scientific Commit- EFSA Working Group. The first meeting to EFSA for the elaboration of an opin- tees and other Agencies, experts from the of the EFSA Working Group took place on ion on Endocrine Disrupting Chemicals three Scientific Committees have been 18-19 October 2012 in Brussels. (EDCs) in collaboration with experts from identified to participate in the work of the workShop on dermal Safety aSSeSSment for SubStanCeS wIth low oral bIoavaIlabIlIty
This workshop took place on 12 November an assessment, do not deliver reliable data assessment strategies for such substances 2012. The safety assessment of cosmetic in this case. This scientific workshop com- were discussed. The outcome of the work- ingredients with very low oral bioavailabil- prised members of the Scientific Commit- shop will serve as a basis for the develop- ity (e.g. UV-filters) is challenging. Oral toxic- tees, industry toxicologists as well as exter- ment of SCCS guidance on this issue.
ity studies, which are usually the basis for nal experts. Suitable safety testing and risk Health and Consumers

the Scientific Committees SCIentIfIC CommIttee on ConSumer Safety (SCCS)
Cosmetic ingredients librium with formaldehyde in aqueous solu- tions. Hair straightening products containing The Annexes to Council Directive 76/768/EEC this ingredient have been suspected to re- Under the safety evaluation of hair dyes, the on cosmetic products do list substances which lease formaldehyde under the conditions of SCCS has recently adopted a number of opin- are banned or restricted for use in cosmetic use, which involve i.a. heating the hair with a ions of which the outcome is as follows: products as well as authorised colorants, UV- hot straightening iron. The SCCS was asked filters and preservatives. For updates of these to assess whether methylene glycol should be Hair dye found to be safe under the intended annexes, the SCCS has to be consulted to car- considered equivalent to formaldehyde, which ry out risk assessments based on safety data is restricted to a maximum concentration of • A5, Toluene-2,5-diamine provided by industry and/or data available in 0.2% in cosmetic products, and to evaluate • A159, 2,3-Diaminodihydroxypyrazolopyra- the public domain.
the safety of use of this ingredient.
zolone dimethosulfonate • B28, Picramic acid and sodium picramate The following risk assessments have recently The SCCS concluded that from a chemical • B50, HC Red n° 3 point of view, there is a close interrelation- • B60, 2-Nitro-5-glyceryl methylaniline ship of formaldehyde and methyleneglycol in • B119, HC Blue 16 aqueous solution. Therefore, the SCCS, in line Acetaldehyde is used as a fragrance/flavour in- with the position of other bodies and panels, gredient in cosmetic products and, as a metab- considered methylene glycol as a formalde- olite of ethanol, can also be present due to the hyde equivalent. Moreover, when methylene use of ethanol or plant extracts. It is classified glycol/formaldehyde is used in hair straight- as carcinogen cat. 2 under the EU chemicals ening products at the maximum authorised legislation. The SCCS was asked to evaluate concentration of 0.2%, the amount of gase- the safety of Acetaldehyde when present up to ous formaldehyde released may exceed the 100 ppm in cosmetic product. WHO indoor air quality guideline for short term exposure. Therefore the SCCS does con- The SCCS concluded that acetaldehyde, based sider the use of methylene glycol/formalde- on life time cancer risk, is not safe at 100 ppm. hyde at 0.2% formaldehyde equivalent not However, as exposure estimates were based on safe in hair straighteners.
a number of worse case considerations, the risk may be overestimated. The SCCS further con- The opinion is available at: cluded that acetaldehyde should not be used as an intended ingredient in cosmetic products except used as a fragrance/flavour ingredient The following hair dyes were found not safe at a maximum concentration of 0.0025% (25 Kojic acid or not possible to assess due to missing data: ppm) in the fragrance compound (as assessed Kojic Acid is used in cosmetic products as a • A75, 6-Amino-m-cresol in the SCCNFP opinion SCCNFP/0821/04), re- skin lightening agent. In a previous opinion • B34, N,N'-bis-(2-hydroxyethylamino) sulting in approximately 2 ppm in the finished in 2008 the SCCP had stated some concerns cosmetic product or 4 ppm in fine fragrances. in relation to the ingredient. On the basis of • C170, Indigofera tinctoria As acetaldehyde has increased the risk of al- additional data the SCCS now re-assessed • C183, Tetrabromophenol Blue cohol-related cancer in particular of the upper the safety of kojic acid and concluded that aero digestive tract, the SCCS concluded that its use at a concentration of 1.0% in leave- The following hair dye was considered to be acetaldehyde should not be intentionally used on creams applied to the face and/or hands safe from the point of view of general toxi- in mouth-washing products.
is safe for the consumers. Concerns remain ity, however concerns were raised due to its The opinion is available at: in situations where the human skin barrier is high allergenic potential: weakened or Kojic Acid is applied on larger • A7, p-Phenylenediamine skin surfaces.
The hair dye opinions are available at: Methylene Glycol The opinion is available at: Methylene glycol is formed upon dissolution of formaldehyde in water and exists in equi- Health and Consumers

the Scientific Committees The Guidance is available at: Benzisothiazolinone is a preservative intend-ed to be used in cosmetic products in a con- Opinion on Zinc oxide, nano-form centration up to 0.01%. The SCCS considered Zinc oxide (CAS No 1314-13-2; EC No 215- benzisothiazolinone safe for use as a preserv- 222-5) has a widespread use in cosmetic ative in cosmetics products up to 0.01% with products and has been previously assessed respect to systemic toxicity, but expressed by the SCCS on its non-nano form. A complete concerns about its sensitising potential. safety dossier on micronsized and nanosized ZnO was requested for the assessment of its The opinion is available at: use in the nano form. The SCCS concluded that based on the available evidence, the use of ZnO nanoparticles with the characteristics as indicated in the submitted dossier, at a Nanomaterials in Cosmetics concentration up to 25% as UV- filter in sun- and cosmetics. Some of these nitrosamines, screens, can be considered not to pose a risk such as N-nitrosodiethanolamine (NDELA) Guidance on the Safety Assessment of Nano- of adverse effects in humans after dermal and N-nitrosodimethylamine (NDMA) are clas- materials in Cosmetics application. This assessment does not apply sified as category 1B carcinogens. Cosmetic The Scientific Committee on Consumers Safety to applications that might lead to inhalation products containing nitrosamines including (SCCS) has produced a Guidance document in exposure to ZnO nanoparticles.
NDELA are banned under the Cosmetics Direc- order to help the cosmetics industry comply tive1 and its Annex III refers to the limit of 50 with the strict conditions and deadlines of The opinion is available at: μg/kg for nitrosamines. When limit values are Article 16 of the Cosmetics Regulation (EC) exceeded, cosmetics containing NDELA and 1223/2009, which will enter into force on 11 balloons containing nitrosamines or nitrosat- July 2013. From then on, the cosmetics indus- able substances are notified by Member State try will have to notify the Commission of all Nitrosamines in Cosmetics authorities to RAPEX. Due to the discrepancies cosmetic products containing nanomaterials, amongst the authorities to classify the risk as six months prior to placing them on the market. Opinion on NDELA in Cosmetic Products and "serious" or "less than serious" the SCCS was The guidance document is specific for nano- Nitrosamines in Balloons consulted in order to provide their view. materials. It adds to the existing SCCS Notes of Nitrosamines are chemical compounds that Guidance for the testing and safety evaluation may be present as contaminants in a number The opinion is available at: of cosmetic ingredients that already provide of products including food (such as certain general guidance to the cosmetics industry.
beverages), tobacco products, rubber products SCIentIfIC CommIttee on health and envIronmental rISkS (SCher)
Cadmium in Fertilizers – Additional Request for adoption of the harmonised measure in 2003? a SCHER opinion on the Risk Assessment report The SCHER stated in its conclusion that the from the Kingdom of Sweden (human health) report does not provide convincing arguments This request was based on a report sub- to show that the Swedish case is a unique one mitted by Sweden. The Kingdom of Sweden or that data which appeared after the adop- has notified the Commission on 17 October tion of Regulation (EC) No 2003/2003 sug- 2011, of its intention to reduce its national gest specific reasons for additional concern. provision on the cadmium content of mineral Overall, the SCHER concluded that it does not phosphate fertilisers from 100 mg Cd/kg P to consider the assumptions made in the Swed- 46 mg Cd/kg P. SCHER issued an opinion on 5 ish report as appropriate for calculating risk in March 2012. Now SCHER was asked the fol- the Swedish environment.
lowing question: Have the Swedish authorities demonstrated that there is a risk to human The opinion is available at: health from Cd in phosphate fertilisers that is specific to Sweden and has arisen after the 1 OJ L 768, 14.10.2008, p.1 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20080424:EN:PDF Entries 410 and 704 in Annex II of the Directive.
Health and Consumers

the Scientific Committees Opinion on tris(2-chloroethyl)phosphate (TCEP) The opinion is available at: recommends the amount allocated to the toy to be limited to 10% of the migration limits, The substance tris(2-chloroethyl)phosphate the Committee concluded that the portion of (TCEP) is an alkyl phosphate ester used as a the TDI for barium allocated to toy exposure flame-retardant plasticiser and viscosity should not exceed 0.02 mg barium/kg bw/day.
regulator in polyurethanes, polyester resins, Mercury in compact fluorescent lamps (CFLs) polyacrylates and other polymers. The Com- In follow-up to the SCHER's opinion on mer- The opinion is available at: mittee concluded that (i) there is no reason cury in lamps and at the request of DG ENER to set any limit for TCEP in toys, since no safe for defensive communication support on the limit could be identified based on the exposure issues, the Chair and rapporteur evaluated from other sources; (ii) the limit should be set a media report in Austria titled ‘Bulb Fiction' Chemicals and the Water Framework Direc- at the detection limit of a sufficiently sensi- which claimed that mercury released when tive: Draft Environmental Quality Standards: tive analytical test method; and (ii ) since the CFLs are accidentally broken result in adverse The Water Framework Directive (WFD, estimated exposure from all possible sources health effects including hair loss and increas- 2000/60/EC) Article 16 requires the Commis- of TCEP, excluding the toy scenario, is close ing a person's susceptibility to other stres- sion to review periodically the list of priority to the provisional TDI value, the use of TCEP sors. In a statement issued the two members substances. Article 8 of the EQSD required should be avoided also in toys intended for of the SCHER provided a scientific rationale the Commission to finalise its next review by use by children older than 3 years of age.
which dispelled the Austrian film allegations. January 2011, accompanying its conclusion, The statement is available at: http://ec.europa.
where appropriate, with proposals to identify The opinion is available at: new priority substances and to set EQSs for them in water, sediment and/or biota.
Assessment of the Tolerable Daily Intake of A shortlist of 19 possible new priority sub- Barium in Toys stances was identified in June 2010. A group The new Toys Safety Directive (TSD) estab- of experts from Member States, EFTA coun- lishes migration limits of 19 elements from tries, candidate countries and more than 25 toys or components of toys. The migration European umbrella organisations represent- limits shall not exceed the listed limits, de- ing a wide range of interests (industry, agri- pending on the toy material used. However, culture, water, environment, etc.) was estab- the elements can be used if the toy or com- lished. This group has been deriving EQS for ponents of the toy exclude any hazard due these substances and has produced draft EQS to sucking, licking, swallowing or prolonged for most of them. In some cases, a consensus contact with the skin when used as intended has been reached, but in some others there or in a foreseeable way, bearing in mind the is disagreement about one or other compo- Mercury in Energy-saving Light Bulbs – behavior of children. nent of the draft dossier. Directorate-General Exposure of children Environment seeks the opinion of the SCHER In particular the potential risk for children is The migration limits are based on a study by on these draft EQS for the proposed priority still causing public concern, resulting in ques- the Dutch National Institute for Public Health substances and the revised EQS for a number tions from members of the European Parlia- and the Environment (RIVM) and opinions of existing priority substances. The SCHER ment and media reports. of the Scientific Committee. In view of the has already published its opinions on aclon- RIVM report and other documents on barium, ifen, anthracene, beta-estradiol, bifenox, cy- This concern has been raised in relation to the SCHER has been asked to deliver an additional butryne, cypermethrin, dichlorvos, diclofenac, issue of mercury emissions from certain en- opinion on the evaluation of the migration dicofol, dioxins, ethinylestradiol, fluoranthene, ergy-saving light bulbs (compact fluorescent limits for barium. Considering that the SCHER HBCDD, heptachlor, ibuprofen, lead, naphtha- lamps, CFLs) upon breakage. In May 2010 lene, nickel, PBDE, polyaromatic hydrocarbons, the SCHER provided an opinion on mercury quinoxyfen, and terbutryne. The work on cya- released from breaking CFLs but at the time nides and nickel continues and is expected to could not conclude on the potential risk of be completed by the end of 2013.
children. Now SCHER has come to an opinion on the potential mercury exposure to children, The following opinion is on Zinc.
and thus the risk. The SCHER considers that short peak inhalation exposures to peak Hg- The opinion is available at: concentrations in air occurring as a result of accidental breakage of CFLs and intakes of Hg above the TDI for a very limited time are unlikely to pose a health risk.
Health and

the Scientific Committees SCIentIfIC CommIttee on emerGInG and newly IdentIfIed health rISkS (SCenIhr)
New Challenges to Risk Assessment The preliminary opinion can be found at: A preliminary opinion was adopted for New Challenges to Risk Assessment. Information about the related public consultation is avail-able on the last page.
opInIon of SCenIhr, SCCS and SCher
the opinion on threshold of toxicological pared with the EFSA opinion on TTC which All opinions delivered by the Scientific Com- was adopted earlier, on 22 May 2012. mittees are without prejudice to personal ethi-cal considerations of the experts. The opinion on TTC was adopted by the three The opinion is available at: Scientific Committees on 8 June 2012. The final draft was carefully examined and com- SCIentIfIC CommIttee on ConSumer Safety - SCCS
The following mandates are currently under Other cosmetic ingredients the skin. It has now been asked to evaluate − Dichloromethane the safety of use of DEGEE in cosmetic prod-ucts which are sprayed and lead to inhalation Hair dyes exposure (e.g. perfumes). To ensure the safety of hair dye products, a − Update to the Notes of Guidance (8th revi- complete review of all hair dye substances on All mandates for the SCCS are available at: the European market has been initiated by the European Commission. Under this framework, NEw MANDAtES foR SCCS full safety evaluations of 3 hair dyes remain to be performed. In addition, supplementary Propyl and butyl paraben data on 114 substances that have been ini- The SCCS has on several occasions performed tially evaluated have been received and are safety assessments on parabens used as cos- under assessment and further data on 12 metic preservatives. It has been asked to eval- substances have been requested. uate a new developmental study performed with propylparaben and to revise, if neces- Preservatives sary, its earlier assessments in the light of this study. In this assessment also the exposure to − Zinc pyrithione sunscreens, especially of children below three years should be taken into account.
UV-filters− HAA299 / C-1332 Diethylene glycol monoethyl ether (DEGEE) − Titanium dioxide (nano-sized) The SCCS has previously assessed this sub-stance taking into account only exposure via Health and Consumers

the Scientific Committees SCIentIfIC CommIttee on health and envIronmental rISkS – SCher
The following mandates are currently under ceramics and gold alloys, is increasing either SCHER to review and update, if appropriate, due to their aesthetic properties or alleged the scientific opinion adopted in May 2008 on health concerns in relation to the use of den- "The environmental risks and indirect health the environmental risks and indirect health effects of mercury in dental amalgam". This effects of mercury in dental amalgam 2008 opinion is available at: In the past the Commission services con- Dental amalgam has been used for over 150 sulted two Scientific Committees on the use years for the treatment of dental cavities and of dental amalgam, the Committee for Envi- is still used, in particular in large cavities, due ronmental and Health Risks (SCHER) and the The new mandate is available at: to its excellent mechanical properties and Committee for Emerging and Newly Identified durability. Dental amalgam is a combination Health Risks (SCENIHR). The opinions of both of alloy particles and mercury that contains Committees were not conclusive regarding about 50% of mercury in the elemental form. the appropriateness of additional regula- The opinion is expected by the end of June Overall, the use of alternative materials, such tory measures to restrict the use of dental as composite resins, glass ionomer cements, amalgam. The Commission now requested SCIentIfIC CommIttee on emerGInG and newly IdentIfIed health rISkS (SCenIhr)
The following mandates are currently under arthroplasty, paying special attention to de- which the European Commission is funding sign and patient groups.
through the LIFE+ programme, has recently issued a press release asserting that "blood New Mandates for SCENIHR The mandate is available at: bags made of DEHP-plasticised PVC pose a significant risk to human health, due to both Safety of metal-on-metal joint replacements DEHP and PVC". In the light of this new study, with a particular focus on hip implants. the Scientific Committee on Emerging and The Scientific Committee on Emerging and Safety of medical devices containing DEHP (di Newly Identified Health Risks (SCENIHR) was Newly Identified Health Risks is requested (2-ethylhexyl) phthalate) plasticized PVC on asked to review and, if appropriate, update to provide a scientific opinion on the safety groups possibly at risk. the opinion adopted in 2008.
of metal-on-metal joint replacements with Various substances are used to ensure flex- a particular focus on hip implants. The Com- ibility of medical devices, among which DEHP The mandate is available at: mittee is asked, in particular, to determine [Di-(2- EthylHexyl) Phthalate] is the most the health effects resulting from metals (in frequently used plasticizer in PVC. DEHP may any form) released by the implanted medical migrate from the device to the human body, device and to identify criteria regarding the resulting in a certain degree of patient ex- The safety of dental amalgam and alternative safety of metal-on-metal implants used in posure. A project entitled PVCfreeBloodBag, dental restoration materials for patients and usersDental amalgam and its substitutes are regu-lated under Council Directive 93/42/EEC con-cerning medical devices, according to which they must comply with the essential require-ments laid out in the directive, in particular in relation to the health and safety of the patients. According to the SCENIHR opinion adopted in May 2008, dental amalgam is a safe material to use in restorative dentistry for patients. No health risk other than an al-lergic reaction in certain individuals can be associated with the use of dental amalgam. The alternatives are not without clinical limi-tations and toxicological hazards and less is known about these alternatives for which available scientific data are more limited. Health and Consumers the Scientific Committees In the light of recent developments and stud- The safety of PIP silicone breast implants The second opinion has been rescheduled to ies on dental amalgam the Commission has asked the Scientific Committee on Emerging The SCENIHR was asked to contribute to the and Newly Identified Health Risks (SCENIHR) creation of an EU questionnaire to collect data The PIP2 questionnaire is available at: to update, if appropriate, the opinion adopted on implanted patients, to provide guidance on in 2008. This opinion is available at: the testing undertaken by the member states, and to update its scientific opinion on the safety of the PIP silicone breast implants on Mandates for SCENIHR are available at: the basis of the new data collected.
The new mandate is available at: Following the rapid scientific opinion adopted by SCENIHR on 1 February 2012 covering "The You may find all information about the work Safety of PIP Silicone Breast Implants", the of the Committees, on the opinions and the The adoption of the opinion is expected by the Commission recognised that an update of this mandates (requests) via the following web- end of June 2013.
opinion would be necessary, mainly because the data available on PIP silicone breast im- plants at the time of the opinion was limited. publIC ConSultatIon for SCenIhr, SCCS and SCher
Public consultation on the Discussion Paper for human and environmental risk assess- addressing the New Challenges for Risk As- ment will change substantially over the next few decades. Those changes will result from advances in scientific knowledge as well as in The European Commission and its 3 inde- modelling and measuring techniques. In ad- pendent, non-food Scientific Committees dition, as regards to human-health risk as- have launched a consultation on the following sessment, a paradigm shift is likely to occur discussion paper: Addressing the New Chal- from a hazard-driven process to one that is lenges for Risk Assessment. The consultation was launched on 22 October 2012 and ran till 30 November 2012. More information can be found at: The motivation for this opinion has been the perception that the procedures currently used Contact details: Health and Consumers

Source: http://www2.nobicon.se/nobicon/func/click.php?docID=920371&UID=2275&delivery=rss&noblink=http://ec.europa.eu/health/scientific_committees/docs/december2012_en.pdf