Opinions adopted
Risk assessment
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Potential risks to human health and the environment from the use of calcium cyanamide as fertiliserAbstract
Adopted by the SCHER during its plenary meeting of 22 March 2016
Potential risks to human health and the environment from the use of calcium cyanamide as fertiliser
SCHER members: Prof. Pim De Voogt (Chair), Dr. Alena Bartonova, Prof. Colin Jansen, Dr. Jadwiga Gzyl, Dr. Renate Krätke, Dr. Jan Linders (Rapporteur), Prof. Greet Schoeters
Contact:SANTE-C2-SCHER
ec [dot] europa [dot] eu (SANTE-C2-SCHER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/66307
Adopted on: 22 March 2016
Content of the Opinion:
Calcium cyanamide, which comprises 44% calcium and 24% nitrogen was first produced in the late 1800s, for use as a fertiliser in the agriculture sector. In 2013, SCHER was asked to assess the potential risks to human health and the environment from using this substance as a fertiliser.
The SCHER calculated human health risks using worker exposure models for the use of calcium cyanamide as fertiliser, based on approaches used for registration of plant protection products. Exposure calculations were made for scenarios where the substance would be used for both professional and private use. Calculations were also made for by-standers and residents, including children.
The SCHER concluded that harmful effects for humans and for the environment could not be excluded when calcium cyanamide is used at the current rates of application.
Keywords:
calcium cyanamide, fertiliser, human toxicity, environmental effects, risk assessment
Opinion to be cited as:
SCHER (Scientific Committee on Health and Environmental Risks), Potential risks to human health and the environment from the use of calcium cyanamide as fertiliser, 22 March 2016.
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New conclusions regarding future trends of cadmium accumulation in EU arable soilsAbstract
Adopted by the SCHER during its plenary meeting of 27 November 2015
New conclusions regarding future trends of cadmium accumulation in EU arable soils
SCHER members: Maria José Carroquino, Raquel Duarte Davidson, Jadwiga Gzyl, Teresa Fernandes, Colin Janssen (Chair), Jan Linders (Rapporteur)
External experts: Marco Vighi (external expert, Rapporteur)
Contact:SANTE-C2-SCHERec [dot] europa [dot] eu (SANTE-C2-SCHER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 27 November 2015
In 2002, the former Scientific Committee for Toxicity, Ecotoxicity and Environment prepared an Opinion on “The Member State Assessments of the Risk to Health and the Environment from Cadmium in Fertilizers” (CSTEE, 2002). Since then, new scientific information has become available. The Commission requested the SCHER to consider whether this new information was of sufficient scientific quality to warrant an update of the CSTEE Opinion of 2002.
Content of the opinion:
The new information provided contains data on the current levels of cadmium in the environment, which now are an order of magnitude lower compared to the data used in 2002. It also includes new estimations of some of the parameters used by CSTEE and a more advanced model that allows a refined calculation. The SCHER concludes that, in general the newly acquired information is of sufficient scientific quality and forms a sound basis for the current assessment. Therefore, the SCHER is of the opinion that the conclusions of the report can be supported and the indicated new, low environmental cadmium (Cd) levels warrant revision of the conclusions presented by CSTEE in 2002
Although the newly acquired information is accepted by the SCHER in general, the SCHER does want to make several recommendations to improve the current modelling results. Indeed, some assumptions cannot be accepted by the SCHER as they are based on insufficiently sound scientific information. For some other parameters the SCHER would prefer another choice for the realistic worst-case assumption provided in the new information. Examples of these suggestions are the upper limit Cd deposition on soils from the atmosphere, the value assumed for the Cd-concentration in manure, the assumed pH of the soils and the assumed organic carbon in EU 27 + Norway soils. In addition, the SCHER suggests a higher worst-case fertiliser input. According to the SCHER, these suggestions may affect the outcome of the model although it is not expected that the results will change dramatically. Nevertheless, a recalculation of the final Cd soil concentrations using these SCHER proposals is recommended.
Keywords:
cadmium, fertiliser, human toxicity, environmental effects, accumulation, arable soils
Opinion to be cited as:
SCHER (Scientific Committee on Health and Environmental Risks), SCHER Opinion on new conclusions regarding future trends of cadmium accumulation in EU arable soils, 27 November 2015.
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Opinion on Environmental risks and indirect health effects of mercury from dental amalgam (update 2014)Abstract
Adopted by the SCHER by written procedure on 10 March 2014 after public consultation
Opinion on Environmental risks and indirect health effects of mercury from dental amalgam (update 2014)
WG on Dental Amalgam - Environmental Effects
SCHER members: Jan Linders (chair from April 2013), Colin Janssen
SCENIHR members:Emanuela Testai
External experts: Marco Vighi, Wolfgang Dekant, John Munth, Nicola Pirrone, Mark Richardson
Contact: SANCO-C2-SCHERec [dot] europa [dot] eu (SANCO-C2-SCHER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/64936
Adopted on: 10 March 2014
Content of the opinion:
Dental amalgam, an alloy of mercury and silver, has been in use for over 150 years for the treatment of dental cavities due to its excellent mechanical properties and durability. Dental amalgam is the second largest use of mercury in the EU, after its use in the chlor-alkali industry. Mercury emissions from dental cabinets are also subject to EU water legislation, as mercury is classified as a priority hazardous substance according to the Water Framework Directive. The Opinion evaluates, in light of the new information available since 2008, if a modification of the scientific assessment of the environmental risks and indirect health effects of mercury in dental amalgam, is necessary. The potential concentration of mercury in surface water has been estimated considering three possible scenarios (worst, average and best case scenario) and compared with the environmental quality standards as set up in the EU legislation in order to identify concentrations which might exceed these standards and may indicate risk to the aquatic ecosystem. Worst and best case represent extreme scenarios but likely to occur in Europe, at least at local level. Another main concern from the contribution of dental amalgam to the total anthropogenic emissions of mercury into the environment is related to the potential of this metal to bioaccumulate and biomagnify through the food chain, resulting in high levels of exposure for top predators (including humans) and associated risk for secondary poisoning. Only for the worst case scenario, under extreme local conditions (maximal dentist density, maximal mercury use, absence of separator devices), the SCHER concludes that mercury concentration might be above the safe threshold established by the European legislation with a potential consequential risk to the aquatic ecosystem, bioaccumulation and the risk for secondary poisoning in humans. This risk depends, however, on the methylation rate of inorganic mercury which may differ with exposure conditions. The SCHER suggests that compliance with the Water Framework Directive’s threshold for mercury would contribute to the safeguard of the ecosystem and also contribute to the prevention of human health effects. With regard to Hg-free alternatives for dental use, the SCHER concluded that information available does not allow a sound environmental risk assessment to be performed.
Keywords:
SCHER, scientific opinion, dental amalgam, mercury
Opinion to be cited as:
SCHER scientific opinion on the environmental risks and indirect health effects of mercury from dental amalgam (update 2014), 10 March 2014.
Toys
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Opinion on Estimates of the amount of toy materials ingested by childrenAbstract
Adopted by the SCHER by written procedure on 8 April 2016
Opinion on Estimates of the amount of toy materials ingested by children
WG on Toys
SCHER members: Claire Beausoleil, Maria José Carroquino, Raquel Duarte Davison, Teresa Fernandes, Renate Krätke (Rapporteur), Greet Schoeters (Chair)
Contact: SANCO-C2-SCHEERec [dot] europa [dot] eu (SANCO-C2-SCHEER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 8 April 2016
Content of the opinion:
The SCHER was asked to review available data on the ingestion of the following three types of toy material by children, and evaluate whether the ingestion amounts which formed the basis for the migration limits of 19 elements in the Toy Safety Directive are still appropriate or should be changed.
1. Dry, brittle, powder-like or pliable toy material (ingestion amount 100 mg/day)
2. Liquid or sticky toy material (400 mg/day)
3. Scraped-off toy material (8 mg/day)In its Opinion the SCHER considers the ingestion amounts mentioned above to be appropriate. Furthermore, the SCHER considers that all ingestion amounts should remain classified as daily amounts rather than weekly.
Keywords:
Toys, children, ingestion, pliable, liquid, sticky, scraped-off toy material, risk assessment
Opinion to be cited as:
SCHER (Scientific Committee on Health and Environmental Risks), Final Opinion on estimates of the amount of toy materials ingested by children, 8 April 2016.
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Opinion on Chromium VI in toysAbstract
Approved by the SCHER at the 10th plenary meeting of 22 January 2015
Opinion on Chromium VI in toys
WG on Chromium VI in Toys
SCHER members: Renate Krätke (Chair and Rapporteur), María José Carroquino, Greet Schoeters, Raquel Duarte-Davidson, Teresa Fernandez
Contact: SANCO-C2-SCHERec [dot] europa [dot] eu (SANCO-C2-SCHER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/41993
Adopted on: 22 January 2015
Content of the opinion:
The European Commission mandated the Scientific Committee on Health and Environmental Risks (SCHER) to consider whether a revision of the migration limits for chromium VI in toys or components of toys, is necessary in view of new available evidence, in particular, with regard to the potential carcinogenic effects of chromium VI. The SCHER evaluated recent data on the cancer potency of chromium VI after oral administration. The occurrence of oral and gastro-intestinal cancer in animals after oral uptake of chromium VI was shown. Due to the genotoxic mode of action there is evidence that carcinogenic effects observed in experimental animals may also be of relevance for humans. A virtual safe dose of 0.0002 μg/kg bw/d was derived and new values for migration limits for chromium VI from toys were recommended accordingly. Given the relatively high background exposure, however, the SCHER is of the opinion that exposure to chromium VI from toys should be minimised to the lowest levels achievable. The SCHER acknowledges that current best available technology may not be sufficient to achieve the new migration limits.
Keywords:
Scientific opinion, chromium VI, toys, virtual safe dose, migration limit, carcinogenicity, oral exposure
Opinion to be cited as:
SCHER (Scientific Committee on Health and Environmental Risks), Final Opinion on Chromium VI in toys, 22 January 2015.
Others
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Final opinion on Synthetic Biology III - Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biologyAbstract
27 November 2015
Final opinion on Synthetic Biology III - Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology
WG on Synthetic Biology
SCENIHR members: Theo Vermeire, Michelle Epstein, Philippe Hartemann, Ana Prokovya, Luis Martinez Martinez
SCHER member: Teresa Fernandes
SCCS members: Qasim Chaudhry, Suresh Chandra Rastog
External experts: Rainer Breitling, Camille Delebecque, Timothy Gardner, Katia Pauwels, James Philp, Markus Schmidt, Eriko Takano
Acknowledgement: Members of the Working Group are acknowledged for their valuable contribution to this Opinion.
Contact: SANCO-C2-SCENIHRec [dot] europa [dot] eu (SANCO-C2-SCENIHR[at]ec[dot]europa[dot]eu), SANCO-C2-SCHERec [dot] europa [dot] eu (SANCO-C2-SCHER[at]ec[dot]europa[dot]eu), SANCO-C2-SCCSec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi:
Adopted on: 27 November 2015
Content of the opinion:
In Opinion I on Synthetic Biology (SynBio), the three Scientific Committees SCHER, SCENIHR and SCCS answered three questions from the European Commission on the scope, definition and identification of the relationship between SynBio and genetic engineering and the possibility of distinguishing the two. The definition reads: Synthetic Biology is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms. In Opinion II, the three Scientific Committees addressed five questions focused on the implications of likely developments in SynBio for humans, animals and the environment and on determining whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms are adequate for SynBio. Additionally, the Scientific Committees were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures including safety locks.
The current Opinion addresses specific risks to the environment from SynBio organisms, processes and products, partly in the context of Decision XI/11 of the Convention of Biodiversity (CBD) (CBD)(CBD)(CBD), identifies major gaps in knowledge to be considered for performing a reliable risk assessment and provides research recommendations resulting from gaps identified. The Scientific Committees confined the scope of their analysis to the foreseeable future, acknowledging that its findings should be reviewed and updated again after several years, depending on the development of the SynBio technology. Outside the scope of the current mandates are specific, thorough analyses of social, governance, ethical and security implications as well as human embryonic research..
Keywords:
Synthetic biology; biotechnology; bioengineering; genetic engineering; microbiology; molecular biology; regulatory framework; genetically modified organisms (GMO); risk assessment; risk assessment methodology; risk mitigation; genetic part libraries; minimal cells; designer chassis; protocells and artificial cells; xenobiology; DNA synthesis and genome editing; citizen science; Do-It-Yourself biology
Opinion to be cited as:
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCHER (Scientific Committee on Health and Environmental Risks), SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCCS (Scientific Committee on Consumer Safety), Synthetic Biology III – Research priorities, Opinion, December 2015.
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Final opinion on Synthetic Biology II - Risk assessment methodologies and safety aspectsAbstract
4 May 2015
Final opinion on Synthetic Biology II - Risk assessment methodologies and safety aspects
WG on Synthetic Biology
SCENIHR members: Theo Vermeire, Michelle Epstein, Philippe Hartemann, Ana Prokovya, Eduardo Rodriguez Farre, Luis Martinez Martinez
SCHER member: Teresa Fernandes
SCCS members: Qasim Chaudhry, Suresh Chandra Rastog
External experts: Rainer Breitling, James Bridges, Camille Delebecque, Timothy Gardner, Katia Pauwels, James Philp, Markus Schmidt, Eriko Takano
Acknowledgement: Members of the Working Group are acknowledged for their valuable contribution to this Opinion.
Contact: SANCO-C2-SCENIHRec [dot] europa [dot] eu (SANCO-C2-SCENIHR[at]ec[dot]europa[dot]eu), SANCO-C2-SCHERec [dot] europa [dot] eu (SANCO-C2-SCHER[at]ec[dot]europa[dot]eu), SANCO-C2-SCCSec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/63529
Adopted on: 4 May 2015
Content of the opinion:
In Opinion I on synthetic biology (SynBio), the three non-food Committees of the European Union SCHER, SCENIHR, and SCCS answered the first 3 out of 11 questions from the European Commission on scope, definition and identification of the relationship between SynBio and genetic engineering, and the possibility of distinguishing the two.
In this second Opinion (Opinion II), the Scientific Committees (SCs) addressed the five subsequent questions focused on the implications of likely developments in SynBio on human and animal health and the environment and on determining whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms (GMOs) are also adequate for SynBio. Additionally, the SCs were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures, including safety locks.
Because SynBio is a rapidly evolving technology, the SCs suggest that risk assessment of and methodology for SynBio must be revisited at regular intervals. Although it is outside the scope of the current mandate, some background considerations about the social, governance, ethical and security implications of SynBio are also provided.
Keywords:
Synthetic biology; biotechnology; bioengineering; genetic engineering; microbiology; molecular biology; Regulatory framework; genetically modified organisms (GMO); risk assessment; risk assessment methodology; risk mitigation; Genetic part libraries; Minimal cells and designer chassis; Protocells and artificial cells; Xenobiology; DNA synthesis and genome editing; Citizen science; Do-It-Yourself biology
Opinion to be cited as:
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCHER (Scientific Committee on Health and Environmental Risks), SCCS (Scientific Committee on Consumer Safety), Synthetic Biology II - Risk assessment methodologies and safety aspects, Opinion, May 2015.
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Final opinion on Synthetic Biology I - DefinitionAbstract
25 September 2014
Final opinion on Synthetic Biology I - Definition
WG on Synthetic Biology
SCENIHR members: Theo Vermeire, Michelle Epstein, Philippe Hartemann, Ana Prokovya, Eduardo Rodriguez Farre, Luis Martinez Martinez
SCHER member: Teresa Fernandes
SCCS members: Qasim Chaudhry, Maria Dusinska, Thomas Platzek, Suresh Chandra Rastog, Jan van Benthem
External experts: Rainer Breitling, James Bridges, Camille Delebecque, Timothy Gardner, Katia Pauwels, James Philp, Markus Schmidt, Eriko Takano
Acknowledgement: Members of the Working Group are acknowledged for their valuable contribution to this Opinion.
Contact: SANCO-C2-SCENIHRec [dot] europa [dot] eu (SANCO-C2-SCENIHR[at]ec[dot]europa[dot]eu), SANCO-C2-SCHERec [dot] europa [dot] eu (SANCO-C2-SCHER[at]ec[dot]europa[dot]eu), SANCO-C2-SCCSec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/76553
Adopted on: 25 September 2014
Content of the opinion:
This Opinion is the first of a set of three Opinions addressing a mandate on Synthetic Biology (SynBio) from the European Commission to the three Scientific Committees (SCs). This first Opinion concentrates on the elements of an operational definition for SynBio. The two Opinions that follow focus on the methodology to determine what, if any, risks SynBio may potentially pose to public health and what type of further research in this field is required.
This first Opinion lays the foundation for the two other Opinions with an overview of the main scientific concepts, developments, tools and research areas in SynBio. Additionally, a summary of relevant regulatory aspects in the European Union (EU), in other countries such as the USA, Canada, South America, China, and at the United Nations is included.
The operational definition offered by the Scientific Committees addresses the need for a definition that enables risk assessment and is sufficiently broad to include new developments in the field. SynBio is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.
This definition has the advantage that it does not exclude the relevant and large body of risk assessment and safety guidelines developed over the past 40 years for GM work and extensions of that work, if needed, to account for recent technological advances in SynBio. Additionally, it enables the rapidly advancing nature of GM technologies and adds an important nuance that supports the need for on-going updates of risk assessment methods, which will be addressed in Opinion II.
It is difficult to accurately define the relationship between genetic modification and SynBio on the basis of quantifiable and currently measurable inclusion and exclusion criteria. Thus, in addition to the definition, a list of specific criteria was considered reflecting that SynBio covers any organism, system, material, product, or application resulting from introduction, assembly, or alteration of the genetic material in a living organism. These criteria are helpful guiding principles that specify whether or not a certain process, tool or product belongs to SynBio, although none are quantifiable or measurable. Additional criteria, including the complexity of the genetic modification, the speed by which modification was achieved, the number of independent modifications, or the degree of computational design methods used, alone or in combination, are also unable to unambiguously differentiate SynBio processes or products from GM.
Keywords:
Synthetic biology, biotechnology, bioengineering, genetic engineering, microbiology, molecular biology, Regulatory framework, genetically modified organisms (GMO), definition
Opinion to be cited as:
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCCS (Scientific Committee on Consumer Safety), SCHER (Scientific Committee on Health and Environmental Risks), Synthetic Biology I Definition, Opinion, 25 September, 2014.
- Opinions SCHER (April 2009 - March 2013)
Details
- Publication date
- 17 November 2015
- Author
- Directorate-General for Health and Food Safety