Scientific Committees

SCHEER - Opinions 2016 - 2021

Opinions being finalised

 

  • 22 March 2017
     

    Scientific advice on Evaluation of new scientific information on the safety of PIP breast implants

    Link to opinion

    WG on PIP breast implants
    SCHEER members: Wim de Jong, Demosthenes Panagiotakos, Theodoros Samaras
    Contact: SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted by written procedure on: 22 March 2017


    Conclusion of the scientific advice:

    Following the request received from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) performed a literature review and launched a call for information to gather new scientific information related to the safety of the PIP breast implants, which became available after the publication of the Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants - Update of the Opinion of February 20126 (2014 Opinion).

    Based on the analysis of the literature review, it is concluded that insufficient new information is available to warrant an update of the 2014 Opinion. New scientific information was found relating to the early and increased PIP implant rupture risk, which suggested that the risk was probably due to the low quality of the implant’s shell as already reported in 2014 Opinion. The calculation of the rupture rate based on PIP explants indicates a rupture rate of PIP breast implants of approximately 23%, similar to the 25% - 30% rupture rate presented in the 2014 Opinion. The call for information did not result in the submission of any scientific data and/or information regarding health effects specific to PIP breast implants. A lot of information was submitted concerning breast implants in general but not focusing specifically on PIP breast implants. This information was considered not relevant for the evaluation of the safety of the PIP breast implants.

    In conclusion, on the basis of the new scientific information gathered, both via the call for information and via the literature review, an update of the 2014 Opinion is not warranted.


    Keywords:

    PIP breast implants, implant failure, safety evaluation, toxicity, silicone, risk assessment


    Scientific Advice to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Evaluation of new scientific information on the safety of PIP breast implants, 22 March 2017.


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  • 5 April 2017
     

    Scientific advice on The state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma

    Link to opinion

    WG on PIP breast implants
    SCHEER members: Wim de Jong, Demosthenes Panagiotakos, Theodoros Samaras
    Contact: SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted by written procedure on: 5 April 2017


    Conclusion of the scientific advice:

    Following the request received from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) performed a literature search and launched a call for information to gather new scientific information related to a possible association between breast implants and anaplastic large cell lymphoma (ACLC).

    The scientific information retrieved from the literature search and the call for data shows that over the past years a body of medical literature on a possible association between breast implants and ALCL has been published, but it consists mainly of case reports, case series and small-scale observational epidemiologic studies.

    Based on the evaluation of this scientific information, the SCHEER acknowledges that there have been new documented cases of ALCL in women with breast implants, worldwide. However, there is currently insufficient scientific information available to establish a methodologically robust risk assessment to investigate a possible association of breast implant with ALCL development.

    The need for registries, throughout the world, of women with breast implants and the systematic evaluation of these registries is a major challenge for providing evidencebased conclusions on the potential association between breast implants and ALCL.

    Therefore the SCHEER recommends keeping this matter under review, i.e. evaluating new scientific data relating to the possible association between breast implants and ALCL in two years.


    Keywords:

    breast implants, anaplastic large cell lymphoma, cancer, PIP breast implants


    Scientific Advice to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) The state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma.


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The commenting period for the scientific advice has expired on 15 June 2017. Comments received by this deadline are (currently) examined by the SCHEER. The advice will be finalised as soon as possible.

Opinions adopted

 

Functioning of the SCHEER

  • Adopted on 23 February 2017
     

    Guidance on the structure and content of SCHEER Opinions and statements

    Link to opinion

    SCHEER WG on WoE
    SCENIHR members: Ana Proykova (Chair), Philippe Hartemann, Emanuela Testai, Theo Vermeire
    SCHER members: Renate Krätke, Alena Bartonova, Claire Beausoleil, Teresa Fernandes, Jan Linders, Greta Schoeters
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 23 February 2017


    In view of the new organisation of the Scientific Committees, namely the merger of two committees (SCHER and SCENIHR) to form the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), the European Commission asked the SCENIHR first and then the SCHEER to produce a guidance document revising the structure and content of scientific Opinions and statements.

    This document aims to provide guidance on how to ensure the high quality of the scientific Opinions and statements in dealing with human healthin dealing with human health in dealing with human health in dealing with human health, environmental and emerging risks.

    The new structure is proposed as an annex to the guidance. It will be tested by the SCHEER for a period of approximately one year and after that, amended if necessary.


    Keywords:

    template, procedure, structure, SCHEER, Opinion


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Guidance on structure and content of SCHEER documents - 23 February 2017.


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Non Animal Testing

  • Adopted on 18 May 2017
     

    Final Opinion on the need for non-human primates in biomedical research, production and testing of products and devices (update 2017)

    Link to opinion

    SCHEER WG on non-human primates testing
    SCHEER members: Peter Hoet, Renate Krätke, Emanuela Testai, Theo Vermeire
    External experts: Romina Aron Badin, Michelle Epstein, Paul Andrew Flecknell, Michelle Hudson-Shore, David Jones, Jan Langermans, Mark Prescott, Alain Simonnard
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 18 May 2017


    Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed recent evidence to update the 2009 Opinion of the Scientific Committee on Health and Environmental Risks (SCHEER) on ‘The need for non-human primates in biomedical research, production and testing of products and devices’.

    This Opinion responds to six main issues in the mandate and highlights the many scientific approaches that could significantly contribute to the replacement, reduction and refinement (3Rs) of Non-Human Primates (NHP) studies and tests. However, there are significant issues that go beyond scientific rationale that prevent widespread adoption and development of alternatives for NHP laboratory use and these are discussed with suggestions of the opportunities to overcome them.

    Although the current state of knowledge does not permit to propose a timetable for phasing-out the use of NHP in Europe, the Opinion provides recommendations on how to advance 3Rs for NHP use, such as through alternative methods, training, improvement of techniques and protocols, sharing of knowledge and removal of barriers. Finally, research needs are given.


    Keywords:

    SCHEER, scientific opinion, non-human primates, biomedical research, toxicity testing, neuroscience, vaccines, infectious diseases, ophthalmology, (xeno)transplantation


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Final Opinion on ‘The need for non-human primates in biomedical research, production and testing of products and devices (update 2017)’, 18 May 2017.


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Physical risks

  • Approved on 6 July 2017
     

    Preliminary Opinion on the potential risks to human health of Light Emitting Diodes (LEDs)

    Link to opinion

    SCHEER WG on LEDs
    SCHEER members: Ana Proykova (Chair), Theodoros Samaras, Rodica Mariana Ion
    External experts: Jean-Francois Doré, Ellen Bruzell, Nicolo Massimo, John O’Hagan (Rapporteur), Celia Sánchez-Ramos, Linda van Kerkhof
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Approved on: 6 July 2017


    Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed recent evidence to assess potential risks to human health of Light Emitting Diodes (LEDs) emissions.

    The review of the published research conducted by the SCHEER has led to valuable conclusions and identified certain gaps in knowledge on potential risks to human health from LEDs.

    The Committee concluded that there is no evidence of direct adverse health effects from LEDs in normal use (lightening and displays) by the healthy general population.

    Vulnerable and susceptible population (young children, adolescent and elderly people) were studied separately. Children have a higher sensitivity to blue light. Although emissions may not be harmful, blue LEDs may be very dazzling for and may induce photochemical retinopathy, which is a concern especially for children below three years of age. Moreover, elderly people may experience discomfort from exposure to LED systems, including blue LED displays (for example, destination displays on the front of buses will be blurred).
    Despite the existence of cellular and animal studies showing adverse effects of LED exposure, their conclusions derive from results obtained using exposure conditions that are difficult to relate to human exposures or using exposure levels greater than those likely to be achieved with LED lighting systems in practice.

    There is a low level of evidence that exposure to light in the late evening, including that from LED lighting and/or screens may have an impact on the circadian rhythm. However, it is not yet clear if this disturbance of the circadian system leads to adverse health effects.

    Since the use of LED technology is still evolving, the Committee considers that it is important to closely monitor the risk of adverse health effects from long term LED use to the general population.


    Keywords:

    Light Emitting Diodes (LEDs), risk assessment, health effects, SCHEER


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Preliminary Opinion on potential risks to human health of Light Emitting Diodes (LEDs), 6 July 2017.


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  • Adopted on 2 February 2017
     

    Final Opinion on Biological effects of UV-C radiation relevant to health with particular reference to UV-C lamps

    Link to opinion

    SCHEER WG on UV-C lamps
    SCHEER members: Theodoros Samaras (Chair), Ana Proykova (Co-rapporteur) Renate Krätke, Rodica Mariana Ion
    SCCS member: Pieter Jan Coenraads
    External experts: Lesley Rushton (Rapporteur), Norbert Leitgeb
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 2 February 2017


    Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed recent evidence to assess health risks associated with UV-C radiation from lamps.
    The part of the ultraviolet radiation emitted in the wavelength range 280 nm–100 nm is called UV-C; this radiation is used in a growing number of applications, which include disinfection of water and air, food-industry processing, and air-conditioning. Although most appliances are sealed systems there is now increasing use of devices where consumers may be directly exposed to UV-C radiation.
    Based on the review and assessment of relevant scientific data, the SCHEER concluded that:

    • Adverse effects to the eye and skin in humans are reported mainly from accidental acute exposure to high levels of UV radiation from UV-C lamps.

    • Mechanistic studies suggest that there are wavelength-dependent exposure thresholds for UV-C regarding acute adverse effects to human eyes and skin, except for erythema. However, quantitative estimation of these thresholds could not be derived from currently available data.

    • Due to the mode of action and induced DNA damage similarly to UVB, UV-C can be considered carcinogenic to humans. However, the currently available data do not allow quantitative cancer risk assessment of exposure from UV-C lamps.

    • UV-C lamps emitting radiation at wavelengths shorter than 240 nm need additional risk assessment of the associated production of ozone in the environment. More data are needed on the exposure of general population and workers from UV-C lamps and generated ozone.

    • Research is needed on long-term stochastic effects such as cancer.


    Keywords:

    UV radiation, UV-C lamps, ozone, risk assessment, cancer, skin, eye


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Opinion on Biological effects of UV-C radiation relevant to health with particular reference to UV-C lamps, 2 February 2017.


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  • Adopted on 17 November 2016
     

    Final Opinion on Biological effects of ultraviolet radiation relevant to health with particular reference to sunbeds for cosmetic purposes

    Link to opinion

    SCHEER WG on Sunbeds
    SCHEER members: Ana Proykova (Chair of the WG since April 2016 and Rapporteur), Theodoros Samaras, Rodica Mariana Ion
    SCCS member: Pieter Jan Coenraads
    External experts:Claire Beausoleil, Jean-Francois Doré (co-Rapporteur), Rüdiger Greinert, Philippe Hartemann, Norbert Leitgeb, Lesley Rushton (Chair of the WG until April 2016), Greet Schoeters
    Contact: SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Approved on: 17 November 2016


    Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks reviewed recent evidence to update the 2006 Opinion of the Scientific Committee on Consumer Products on the Biological effects of ultraviolet radiation (UVR) relevant to health, with particular reference to sunbeds for cosmetic purposes. The term “sunbed” refers to all types of UV tanning devices used for cosmetic purposes.

    UVR, including UVR emitted by sunbeds, is a complete carcinogen, as it acts both as an initiator and a promoter. The SCHEER concludes that there is strong evidence that exposure to UVR, including that emitted by sunbeds, causes cutaneous melanoma and squamous cell carcinoma at all ages and that the risk for cancer is higher when the first exposure takes place in younger ages. There is moderate evidence that exposure to UVR, including that emitted by sunbeds, also increases the risk of basal cell carcinoma and ocular melanoma.

    The potentially beneficial effects of sunbed use such as generation of vitamin D are outweighed by the adverse effects. There is no need to use sunbeds to induce Vitamin D production.

    There is no threshold level of UV-irradiance and UV–dose for the induction of skin cancer. Therefore, there is no safe limit for exposure to UV radiation from sunbeds.


    Keywords:

    Ultraviolet radiation, UV-tanning devices, Sunbeds, Health effects, Risk assessment, SCHEER


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Opinion on Biological effects of ultraviolet radiation relevant to health with particular reference to sunbeds for cosmetic purposes, 17 November 2017.


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Public Health

  • Adopted on 16 December 2016
     

    Final Opinion on Additives used in tobacco products (Tobacco Additives II)

    Link to opinion

    SCHEER WG on Tobacco additives
    SCHEER members: Emanuela Testai (Chair and Rapporteur), Raquel Duarte-Davidson, Peter Hoet, Theo Vermeire, Sergej Zacharov
    External experts: Urmila Nair, Reinskje Talhout, (Rapporteur), Konrad Rydzynski
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 16 December 2016


    Stemming from Tobacco Products Directive 2014/40/EU and from a previous SCENIHR Opinion (Tobacco Additives I), the Commission has established a priority list of 15 additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations that is to be updated on a regular basis. For these additives included in the priority list, manufacturers and importers of tobacco products must carry out comprehensive studies.

    In the second Opinion (Tobacco Additives II) the SCHEER was asked to provide guidance on the type and criteria for comprehensive studies, and the most suitable methodologies to be used for the first list of 15 priority additives and for future updated lists.

    The SCHEER proposes a step-wise strategy as the most pragmatic and efficient way to proceed in the assessment of the toxic, and addictive effects as well as and characterising flavour properties and to minimise testing.

    In addition, the SCHEER analysed major data gaps for the 15 additives included in the priority list of additives which generally relate to information on addictiveness and attractiveness, as well as on the identity of the pyrolysis products.


    Keywords:

    tobacco, additives, combustion products, cigarettes, roll-your-own, smoking, toxicity, addictiveness, characterising flavour, facilitated inhalation


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Additives used in tobacco products, Opinion 2, 16 December 2016.


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Rapid risk assessment

  • Adopted on 02 February 2017
     

    Guidance on ad hoc rapid risk assessment of serious cross-border chemical health threats performed by the SCHEER

    Link to opinion

    WG on rapid risk assessment
    SCHER former members: Claire Beausoleil, María José Carroquino, Raquel Duarte Davidson (Chair and Rapporteur), Teresa Fernandes, Colin Janssen, Renate Krätke, Jan Linders, Greta Schoeters
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 02 February 2017


    Content of the Opinion

    The European Commission asked the Scientific Committee on Health and Environmental Risks (SCHER) and its successor, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) a guidance document illustrating the procedure to be followed by the SCHEER for the provision of ad hoc rapid risk assessments in case of cross border chemical health threats.

    The SCHEER has been tasked with coordinating the response in case of cross border chemical health threats to support the Commission, as laid down by Decision 1082/2013/EU on serious cross border threats to health. These threats include both manmade and naturally occurring events (e.g. chemicals released during an incident or during a volcanic eruption) that may have an impact on public health. The rapid risk assessment does not cover the wider effects on the environment.

    This document presents the procedure to be followed by the SCHEER for the provision of such ad hoc rapid risk assessments.


    Keywords:

    template, procedure, rapid risk assessment


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Guidance on ad hoc rapid risk assessment of serious cross-border chemical threats performed by the SCHEER, 2 February 2017.


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Toys

  • Adopted on 05 July 2017
     

    Preliminary Opinion on Tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys

    Link to opinion

    WG on aluminium in toys
    SCHEER members: Teresa Borges, Raquel Duarte-Davidson, Rodica Mariana Ion, Renate Krätke, Emanuela Testai, Sergej Zacharov
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 05 July 2017


    Content of the Opinion

    Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) hereby reviews the currently available data on the toxicity of aluminium, taking into account the different tolerable intake levels for aluminium established by the European Food Safety Authority in 2008 and by the Joint FAO/WHO Expert Committee on Food Additives in 2011, and presents its recommendation for a tolerable intake level for aluminium based on most recent data that could be used to adapt the migration limits for aluminium in the Toy Safety Directive 2009/48/EC, taking into account the exposure to aluminium from sources other than toys.

    The SCHEER is of the opinion that at for the time being the study by Poirier et al. from 2011 is the fundamental onlystudy for the derivation of a health-based limit value. Using the NOAEL of 30 mg/kg bw/d from this study (based on neuro-developmental effects seen at 100 mg/kg bw/d) as the Point of Departure and applying the default assessment factor of 100, a tolerable daily intake (TDI) of 0.3 mg/kg bw/d is considered appropriate by the SCHEER for the calculation of migration limits for aluminium from toys.

    The resulting migration limits for aluminium from toys, calculated according to the current legislation, which allocates 10% of the tolerable daily intake to toys, are 2250 mg aluminium/kg of dry, brittle, powder-like or pliable toy material, 560 mg aluminium/kg of liquid or sticky toy material and 28130 mg aluminium/kg of scraped-off toy material.

    However, the SCHEER noted that exposure to aluminium from sources others than toys, in particular from diet, which is by far the major source of chronic exposure, may already exceed the PTWI reference value for tolerable weekly intake as derived by JECFA. Therefore, the SCHEER recommends that the additional exposure from toys should be minimised.


    Keywords:

    Scientific opinion, aluminium, toys, migration limit, exposure


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys. 5 July 2017.


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Water Quality

  • Adopted via written procedure on 15 September 2017
     

    Scientific advice on Guidance Document n°27: Technical Guidance for Deriving Environmental Quality Standards

    Link to opinion

    WG on water reuse
    SCHEER members: Teresa Borges, Raquel Duarte Davidson (Chair), Marian Scott, Marco Vighi (Rapporteur), Pim de Voogt
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 15 September 2017


    Content of the Opinion

    Following a request from the Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed the Guidance Document No. 27: ‘Technical Guidance for Deriving Environmental Quality Standards’ prepared by a collaborative framework (the Common Implementation Strategy) for the Water Framework Directive. The SCHEER concludes that the overall scientific quality of the proposed changes is an improvement to the earlier 2011 version. The SCHEER has a number of comments where more practical guidance can be provided or where the current state of knowledge is still insufficient or where it is not being fully utilised.


    Keywords:

    Water Framework Directive, environmental quality standards


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Scientific Advice on Environmental Quality Standards, 15 September 2017.


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  • Adopted on 09 June 2017
     

    Scientific advice on Proposed EU minimum quality requirements for water reuse in agricultural irrigation and aquifer recharges

    Link to opinion

    WG on water reuse
    SCHEER members: Renate Krätke, Marian Scott, Marco Vighi, Pim de Voogt
    External experts: Jan Linders, Luigi Rizzo
    Contact:SANTE-C2-SCHEER@ec.europa.eu
    On request from: European Commission
    Adopted on: 09 June 2017


    Content of the Opinion

    Following a request from the Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) reviewed the report prepared by the European Commission Joint Research Centre on “Proposed EU minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge".

    The SCHEER concludes that, while the methodology chosen is appropriate and the report considers many important elements, the document is deficient in key details. The SCHEER recommends that the description of the methodology be extended and detailed guidance be provided on how minimum quality requirements should be derived. The SCHEER is of the opinion that, in its current form, the minimum quality requirements proposed provide insufficient protection both to environmental and human health.


    Keywords:

    water reuse, agricultural irrigation, aquifer recharge, minimum quality requirements


    Opinion to be cited as:

    SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Scientific advice on Proposed EU minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge, 9 June 2017.


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Previous committees:

- SCHER - Opinions (2013-2016)
- SCENIHR - Opinions (2013-2016)