Awaiting committee decision
2015/2259(INI) Implementation of the Food Contact Materials Regulation (EC) No 1935/2004
Lead committee dossier: ENVI/8/03960
Legal Basis RoP 052
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI | SCHALDEMOSE Christel (S&D) | COLLIN-LANGEN Birgit (EPP), JÄÄTTEENMÄKI Anneli (ALDE) |
Legal Basis RoP 052
Subjects
Activites
-
2015/10/29
Committee referral announced in Parliament, 1st reading/single reading
Documents
| Amendments | Dossier |
| 166 |
2015/2259(INI)
166/01/03
ENVI
166 amendments...
Amendment 1 #
Motion for a resolution Citation 1 a (new) - having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(7) ('the REACH Regulation')1a, _________________ 1a OJ L 396, 30.12.2006, p. 1–849
Amendment 10 #
Motion for a resolution Citation 5 d (new) - having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93, and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(7) ('the REACH Regulation')1a , _________________ 1a OJ L 396, 30.12.2006, p. 1–849
Amendment 100 #
Motion for a resolution Paragraph 8 e (new) 8e. Underlines that FCMs are a significant source of human exposure to chemicals of concern, including perfluorinated compounds (PFCs) and endocrine disrupting chemicals (EDCs) such as phthalates and bisphenols, which have been linked to chronic diseases in animal tests and epidemiology studies; thus, calls on the Commission to include in-vitro screening for EDC activity as a mandatory requirement;
Amendment 101 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to ensure better coordination between Regulation (EU) No 1907/2006 (REACH)1a and the FCM
Amendment 102 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to ensure better coordination between the REACH and FCM legislation,
Amendment 103 #
Motion for a resolution Paragraph 9 9. Calls on the Commission
Amendment 104 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to ensure better coordination between REACH and FCM legislation, especially as regards substances classified as S
Amendment 105 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to ensure better coordination between REACH and FCM legislation, especially as regards substances classified as SVHCs under REACH, and to ensure that
Amendment 106 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to ensure better coordination between REACH and FCM legislation, especially as regards substances classified as SVHCs under REACH, to consider identifying Bisphenol A (BPA) as one of the substances classifed as SVHCs and to ensure that harmful substances phased out under REACH are also phased out in FCMs;
Amendment 107 #
Motion for a resolution Paragraph 9 9. Calls on the Commission to ensure better coordination between REACH and FCM legislation, especially as regards substances classified as SVHCs under REACH, and to ensure, by means of regular consultation procedures, that harmful substances phased out under REACH are also phased out in FCMs;
Amendment 108 #
Motion for a resolution Paragraph 9 a (new) 9a. The 58 chemicals that have been placed on the list of most harmful chemicals under the REACH Regulation1a (SVHC) are currently permitted in food contact materials; they include chemicals that are carcinogenic, mutagenic or toxic to reproduction, or are bio-accumulative (i.e. capable of building up and persisting in the body), or have hormone disrupting or other harmful properties; FCMs-related concern also refers to endocrine disrupting chemicals (EDCs), which are associated with hormonal cancers (breast, prostate, testes) as well as reproductive problems (infertility, adverse pregnancy outcomes), metabolic disorders (diabetes, obesity), allergies, and neurodevelopmental problems (learning disorders, autism spectrum disorders). In addition to known hazardous chemicals, there are other chemicals (so- called non intentionally added substances) that migrate, and their identity and structure is not known (especially in plastics). _________________ 1a OJ L 396, 30.12.2006, p. 1–849
Amendment 109 #
Motion for a resolution Paragraph 9 a (new) 9a. Calls on the Commission to remedy as much as possible to the current illegal delay in the adoption of criteria for defining endocrine disrupting chemicals by reassessing all substances authorised or renewed in the EU since 14 December 2013 against the EDC criteria as soon as they are published and by accordingly reviewing the authorisations and reapprovals so far delivered;
Amendment 11 #
Motion for a resolution Recital A A. whereas Regulation (EC) No 1935/2004 (‘the Framework Regulation’) sets out general safety requirements for all food contact materials
Amendment 110 #
Motion for a resolution Paragraph 9 a (new) 9a. Welcomes the Commission's ongoing work on defining criteria for determining the endocrine-disrupting properties of chemicals; calls for the inclusion of these criteria in the risk assessment procedure of FCMs in order to eliminate genotoxic substances and endocrine disrupting chemicals from FCMs;
Amendment 111 #
Motion for a resolution Paragraph 9 a (new) 9a. Calls on EFSA to consolidate the emerging scientific knowledge on nanomaterial use in FCMs, their migration and potential impact on human health by applying special evaluation procedures which take fully into account the peculiarities linked to their dimensions;
Amendment 112 #
Motion for a resolution Paragraph 9 a (new) 9a. Calls on the Commission to align the forthcoming identification criteria for endocrine disruptors with the FCM legislation, in particular so as to meet the general requirement that such materials must not endanger human health;
Amendment 113 #
Motion for a resolution Paragraph 9 b (new) 9b. Supports further research into nanomaterials as there is still scientific uncertainty regarding the effects and migration capability of these materials; Believes therefore that nanomaterials should not only be subjected to authorisation for use in plastic materials, but in all FCM materials, and should be assessed not only in their bulk form;
Amendment 114 #
Motion for a resolution Paragraph 10 10. Welcomes the fact that the Commission has finally announced its plan to introduce a migration limit of 0.05 mg/kg for Bisphenol A (BPA) for packaging and containers made of plastic, as well as for varnishes and coatings used in metal containers
Amendment 115 #
Motion for a resolution Paragraph 10 10.
Amendment 116 #
10.
Amendment 117 #
Motion for a resolution Paragraph 10 10. Welcomes the fact that, following the recent EFSA opinion, the Commission has finally announced its plan to introduce a migration limit of 0.05 mg/kg for Bisphenol A (BPA) for packaging and containers made of plastic, as well as for varnishes and coatings used in metal containers; considers this an improvement compared to the current migration limit of 0.6 mg/kg for BPA in plastic; regrets that this migration limit does not apply to all FCMs;
Amendment 118 #
Motion for a resolution Paragraph 10 10. Welcomes the fact that the Commission has finally announced its plan to introduce a migration limit of 0.05 mg/kg for Bisphenol A (BPA) for packaging and containers made of plastic, as well as for varnishes and coatings used in metal containers; considers this an improvement compared to the current migration limit of 0.6 mg/kg for BPA in plastic; regrets that
Amendment 119 #
Motion for a resolution Paragraph 10 10. Welcomes the fact that the Commission has finally announced its plan to introduce a migration limit of 0.05 mg/kg for Bisphenol A (BPA) for packaging and containers made of plastic, as well as for varnishes and coatings used in metal containers; considers this an improvement compared to the current migration limit of 0.6 mg/kg for BPA in plastic;
Amendment 12 #
Motion for a resolution Recital C a (new) Ca. whereas there is a strong need for revision of current harmonised legislation, specifically Council Directive 84/500/EEC on ceramics 1a; _________________ 1a OJ L 277, 20.10.1984, p.12
Amendment 120 #
Motion for a resolution Paragraph 10 10.
Amendment 121 #
Motion for a resolution Paragraph 10 10.
Amendment 122 #
Motion for a resolution Paragraph 10 a (new) 10a. Understands that the Commission is looking at the limits for lead and cadmium in the implementing measure on ceramic articles (Council Directive 84/500/EEC)1a; strongly urges the Commission to come forward with a legislative proposal introducing lower limits for the release of lead and cadmium; _________________ 1a OJ L 277, 20.10.1984, p. 12
Amendment 123 #
Motion for a resolution Paragraph 11 11. Supports research and innovation initiatives that seek to develop new substances for use in FCMs that are proven to be safe for human health;
Amendment 124 #
Motion for a resolution Paragraph 11 11. Supports research and innovation initiatives that seek to develop not only new substances for use in FCMs that are proven to be safe for human health, but also alternative processes and product designs; thus, calls on the Commission to promote the exchange of best practices among Member States and the dissemination of successful pilot projects;
Amendment 125 #
Motion for a resolution Paragraph 11 11. Supports research and innovation initiatives that seek to develop new substances for use in FCMs that are proven
Amendment 126 #
Motion for a resolution Paragraph 11 11. Supports research and innovation initiatives that seek to develop new substances for use in FCMs that are proven to be safe for human health, which in turn can increase the competitiveness of European products;
Amendment 127 #
Motion for a resolution Paragraph 11 11. Supports research and innovation initiatives that seek to develop new substances for use in FCMs that are proven to be safe for human health, and for the environment once they become waste;
Amendment 128 #
Motion for a resolution Paragraph 11 a (new) 11a. Stresses that labelling plays an important part in the implementation of regulations on FCM and therefore has a direct impact on the effective functioning of the internal market and on the safety of FCM; observes that the information required should be exhaustive, clearly legible and indelible, and calls on Member States in whose territory articles or FCM are sold to negotiate agreements to ensure that the labels concerned are written in one or more EU official languages;
Amendment 129 #
Motion for a resolution Paragraph 11 a (new) 11a. Points out that market barriers, and in particular petitioning for authorisations under differing national rules, results in loss of opportunities for food safety improvement via innovation.
Amendment 13 #
Motion for a resolution Recital D a (new) Da. Whereas a system of mutual recognition of widely diverging national FCMs legislation cannot ensure the high level of health protection envisaged by the EU Treaty;
Amendment 130 #
Motion for a resolution Paragraph 12 12. Believes that a Declaration of Compliance (DoC) can be an effective tool for ensuring that FCMs are compliant with the relevant rules, and recommends that all FCMs, whether harmonised or non- harmonised, are accompanied by a DoC and the appropriate documentation, as is currently the case for FCMs for which specific measures have been adopted; conditions of use should be better reflected in the relevant declarations of compliance;
Amendment 131 #
Motion for a resolution Paragraph 12 12. Believes that a Declaration of Compliance (DoC)
Amendment 132 #
Motion for a resolution Paragraph 12 12. Believes that a Declaration of Compliance (DoC) can be an effective tool for ensuring that FCMs are compliant with the relevant rules, and recommends that all FCMs, whether harmonised or non- harmonised, are accompanied by a high- quality DoC and the appropriate documentation, as is currently the case for FCMs for which specific measures have been adopted;
Amendment 133 #
Motion for a resolution Paragraph 12 12.
Amendment 134 #
Motion for a resolution Paragraph 14 14. Calls for the traceability and
Amendment 135 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on the Commission to establish mandatory labelling of the intended presence of nanomaterials in food contact materials and to establish mandatory labelling of the composition of the food contact materials used for organic products and products intended for critical groups;
Amendment 137 #
Motion for a resolution Paragraph 15 15. Expresses its concern that the level of enforcement of the legislation on FCMs varies greatly across the EU; highlights the importance of developing
Amendment 138 #
Motion for a resolution Paragraph 15 15. Expresses its concern that the level of enforcement of the legislation on FCMs varies greatly across the EU; highlights the importance of developing EU guidelines for FCMs which would facilitate a more uniform implementation and better enforcement in the Member States; believes that other non-legislative policy options, such as the experience of industry self-assessment, should supplement measures to improve the enforcement of the Framework Regulation on FCMs;
Amendment 139 #
Motion for a resolution Paragraph 15 15. Expresses its concern that the level of enforcement of the legislation on FCMs varies greatly across the EU; highlights the importance of developing EU guidelines for FCMs which would facilitate a more uniform implementation and better enforcement in the Member States; to this end, underlines the importance of sharing data between Member States;
Amendment 14 #
Motion for a resolution Recital E E. whereas materials not regulated by
Amendment 140 #
Motion for a resolution Paragraph 15 15. Expresses its concern
Amendment 141 #
Motion for a resolution Paragraph 15 15. Expresses its concern that the level of enforcement of the legislation on FCMs varies greatly across the EU; highlights the importance of developing EU guidelines for FCMs which would facilitate a
Amendment 142 #
Motion for a resolution Paragraph 15 a (new) 15a. Considers that Member States should be permitted to ban endocrine disrupters in materials intended to come into contact with food, failing the publication by the Commission of criteria for the definition of endocrine disrupters;
Amendment 143 #
Motion for a resolution Paragraph 15 a (new) 15a. Takes the view that further harmonisation of food contact materials and articles can help to bring about a uniformly high level of public health protection;
Amendment 144 #
Motion for a resolution Paragraph 16 16. Recommends the
Amendment 145 #
Motion for a resolution Paragraph 16 16. Recommends the development of a single EU standard for analytical testing in order to ensure that FCMs are tested by companies and competent authorities across the EU using one and the same method; considers that EU single standards should be appropriate and specifically developed for each food contact material, taking into account different risks associated with different materials;
Amendment 146 #
Motion for a resolution Paragraph 16 16. Recommends the development of a single EU standard for analytical testing in order to ensure that FCMs are tested by companies and competent authorities across the EU using one and the same method; highlights that such EU single standards and tests have to be specifically developed for each food contact material according to its final use;
Amendment 147 #
Motion for a resolution Paragraph 16 16. Recommends the development of
Amendment 148 #
Motion for a resolution Paragraph 16 16. Recommends the development of a single EU standard for analytical testing in order to ensure that FCMs are tested by companies and competent authorities across the EU using one and the same method; considers that such standards must be tailored towards the characteristics of each individual FCM;
Amendment 149 #
Motion for a resolution Paragraph 16 16. Recommends the development of a single EU standard for analytical testing for each FCM in order to ensure that FCMs are tested by companies and competent authorities across the EU using
Amendment 15 #
Motion for a resolution Recital E E. whereas materials not regulated by specific EU measures can pose a risk to public health and give rise to loss of consumer trust, legal uncertainty and increased compliance costs for operators; whereas the
Amendment 150 #
Motion for a resolution Paragraph 16 16.
Amendment 151 #
Motion for a resolution Paragraph 16 a (new) 16a. Welcomes that such a standard exists for regulated materials including ceramics, plastics etc.; believes that setting absolute limits for heavy metals in pigments and colours authorised for use in the ceramics, porcelain and glass production is of highest importance; calls for simplification of the enforcement of EU legislation in the sense of setting the standards as absolute values instead of migration limits; stresses that the migration limits for heavy metals such as lead and cadmium constitute a financial and personnel burden on competent authorities and that determining the limits by using the methodology of migration in acetic acid 4%, at 22°C for 24 hours is expensive and time consuming; underlines that modern, more sophisticated technology may be used for quick, non-invasive testing and alternatively, the limits for toxic metals in ceramics may be set further up the industry chain;
Amendment 152 #
Motion for a resolution Paragraph 16 a (new) 16a. Believes that a single EU standard for analytical testing for each FCM is crucial as harmonized rules are developed for these FCMs, given the uncertainty caused by the principle of mutual recognition in some instances;
Amendment 153 #
Motion for a resolution Paragraph 17 17. Stresses that it is the responsibility of each Member State to carry out controls on companies that produce or import FCMs; regrets, however, that some Member States do not impose the requirement for companies to register their business activity, thereby allowing such companies to circumvent conformity controls; calls on the Commission to revise the Framework Regulation, so as to require that all remaining Member States impose an obligation on all companies producing or importing FCMs to officially register their business activity; recognises the existence of suitable registration mechanisms in several Member States which can serve as examples for Member States who still have to put a registration obligation in place;
Amendment 154 #
Motion for a resolution Paragraph 17 17. Stresses that it is the responsibility of each Member State to carry out controls on companies that produce or import FCMs; regrets, however, that some Member States do not impose the requirement for companies to register their business activity, thereby allowing such companies to circumvent conformity controls; calls on the Commission to revise the Framework Regulation, so as to require that Member States impose an obligation on all companies producing or importing FCMs to officially register their business activity; recognizes the existence of suitable registration mechanisms in several Member States which can serve as examples of best practices for regulation at the EU level;
Amendment 155 #
Motion for a resolution Paragraph 17 17. Stresses that it is the responsibility of each Member State to carry out controls on companies that produce or import FCMs; regrets, however, that some Member States do not impose the requirement for companies to register their
Amendment 156 #
Motion for a resolution Paragraph 17 17. Stresses that it is the responsibility of each Member State to carry out controls on companies that produce or import FCMs; regrets, however, that some Member States do not impose the requirement for companies to register their business activity, thereby allowing such companies to circumvent conformity controls; calls on the Commission to revise the Framework Regulation, so as to require that Member States that have not already done so, impose an obligation on all companies producing or importing FCMs to officially register their business activity;
Amendment 157 #
17. Stresses that it is the responsibility of each Member State to carry out controls on companies that produce or import FCMs; regrets, however, that some Member States do not impose the requirement for companies to register their business activity, thereby allowing such companies to circumvent conformity controls; calls on the Commission to re
Amendment 158 #
Motion for a resolution Paragraph 17 a (new) 17a. Welcomes the Commission's 'Better Training for Safer Food' platform; calls for its activities to be expanded;
Amendment 159 #
Motion for a resolution Paragraph 18 18. Calls on the Member States to carry out controls more efficiently, on the basis
Amendment 16 #
Motion for a resolution Recital E E. whereas materials not regulated by
Amendment 160 #
Motion for a resolution Paragraph 18 18. Calls on the Member States to
Amendment 161 #
Motion for a resolution Paragraph 18 18. Calls on the Member States to carry out controls more systematically and efficiently, on the basis
Amendment 162 #
Motion for a resolution Paragraph 18 18. Calls on the Member States to carry out controls more efficiently
Amendment 163 #
Motion for a resolution Paragraph 19 19. Insists on the need for Member States to ensure that they have the necessary staff trained to perform uniform and robust controls
Amendment 164 #
Motion for a resolution Paragraph 19 19. Insists on the need for Member States to ensure that they have the necessary staff trained and schooled to perform uniform
Amendment 165 #
Motion for a resolution Paragraph 19 19. Insists on the need for Member States to ensure that they have the necessary staff
Amendment 166 #
Motion for a resolution Paragraph 19 a (new) 19a. Calls for more effective cooperation and coordination between the Member States and the Commission on the early warning system for foodstuffs and feedingstuffs, so that risks to public health can be dealt with quickly and effectively;
Amendment 17 #
Motion for a resolution Recital E E. whereas materials not regulated by specific EU measures can pose a risk to public health and give rise to loss of consumer trust, legal uncertainty and increased compliance costs for operators which are eventually covered by end consumers; whereas the lack of uniform measures is detrimental to the smooth functioning of the internal market and hampers the drive towards a circular economy;
Amendment 18 #
Motion for a resolution Recital E a (new) Ea. Whereas particularly endocrine disruptors and genotoxic substances in FCMs are problematic both for public health and the environment; whereas currently, these activities cannot be reliably predicted from the chemical composition, and therefore biotesting should be encouraged as a an optional premonitory measure to ensure the safety of chemically complex FCMs; whereas research on the development of both analytical and toxicological testing should be encouraged to ensure robust and cost- effective safety assessment of FCMs for the benefit of consumers, environment and manufacturers;
Amendment 19 #
Motion for a resolution Recital E a (new) Ea. whereas the internal market for the four harmonised products groups is working well; whereas many Member States have introduced or are working on different measures for the remaining individual food contact materials and articles; whereas in respect of these national measures the principle of mutual recognition does not work and the effective functioning of the internal market is thus being impeded;
Amendment 2 #
Motion for a resolution Citation 2 a (new) - having regard to the Commission State of the Art Report on Mixture Toxicity1a, _________________ 1a Kortenkamp 2009 http://ec.europa.eu/environment/chemical s/effects/pdf/report_mixture_toxicity.pdf
Amendment 20 #
Motion for a resolution Recital E a (new) Ea. whereas the traceability of FCM should be ensured at all stages of the supply chain in order to facilitate monitoring, the recall of defective products, consumer information and the attribution of responsibility.
Amendment 21 #
Motion for a resolution Recital E a (new) Ea. Whereas deleterious microorganisms (pathogenic or spoilage) that may be present as contaminants of FCMs, and the biocides that may be consequently used to reduce their number, also pose a risk to public health;
Amendment 22 #
Motion for a resolution Recital E a (new) Ea. whereas the initiatives of certain Member States to ban endocrine disrupters are salutary and fill the void left by the Commission's inaction;
Amendment 23 #
Motion for a resolution Recital E a (new) E a. whereas current EU legislation is not unequivocal as regards whether Member States are required to register FCM producers in the interests of the monitoring of food safety;
Amendment 24 #
Motion for a resolution Recital E b (new) Eb. whereas effective implementation of the regulation on materials intended to come into contact with food requires the publication of criteria for defining endocrine disrupters;
Amendment 25 #
Motion for a resolution Recital E b (new) Eb. whereas the aim of the framework regulation could be achieved if uniform EU testing methods were to be developed for all food contact materials and articles;
Amendment 26 #
Motion for a resolution Recital E c (new) Ec. whereas introducing a safety check for pre-manufactured food contact articles could be one way of supplementing certain specific measures;
Amendment 27 #
Motion for a resolution Recital E d (new) Ed. whereas the lack of uniform specific measures will make it impossible to achieve the aims of the framework regulation, with the result that the effective functioning of the internal market and a high degree of protection of public health and consumers' interests cannot be guaranteed;
Amendment 28 #
Motion for a resolution Recital E e (new) Ee. whereas the more effective coordination of all provisions which have a bearing on the use of food contact materials and articles could help to improve consumer health protection and reduce the impact of packaging materials on the environment, and whereas at the same time this would do much to make the circular economy more effective;
Amendment 29 #
Motion for a resolution Recital F a (new) Fa. whereas a European Implementation Assessment study by the European Parliamentary Research Service of May 2016 concludes that stakeholders - across businesses, consumers, environmental and health NGOs, researchers, as well as Member States' competent authorities - are in favour of specific measures at EU level for the FCMs that are not yet harmonised at EU level;
Amendment 3 #
Motion for a resolution Citation 2 b (new) - having regard to the conclusions adopted by the Council of Environment Ministers on 22 December 2009 on the combination effects of chemicals 1a , _________________ 1a http://register.consilium.europa.eu/doc/sr v?l=EN&f=ST%2017820%202009%20IN IT
Amendment 30 #
Motion for a resolution Recital F a (new) Fa. whereas there are EU laws which aim to protect public health from exposure to chemicals in products and from the environment, but which only assess risks individually and do not provide for a comprehensive, integrated assessment of the cumulative effects from different routes of exposure and different product types;
Amendment 31 #
Motion for a resolution Recital F a (new) Fa. whereas the current paradigm of health and environmental risk assessment at EU level is limited to assessment of individual substances and ignores the real life conditions of combined and cumulative exposure from different routes and product types, also known as "cocktail" or "mixture" effect;
Amendment 32 #
Motion for a resolution Recital F a (new) Fa. whereas some foods are in contact for long periods with a wide range of packaging materials;
Amendment 33 #
Motion for a resolution Recital F b (new) Fb. whereas the "Better Regulation" principles should by no means delay any measure aiming at averting or reducing potentially serious or irreversible consequences for human health and/or the environment, as compelled by the precautionary principle enshrined in the EU Treaties;
Amendment 34 #
Motion for a resolution Recital F c (new) Fc. whereas full transparency of the protocols, raw data and results of scientific studies is a prerequisite for trustworthy public decision making and avoiding duplicative testing on vertebrate animals;
Amendment 35 #
Motion for a resolution Recital F d (new) Fd. whereas according to a recommendation by FAO/WHO (2009)1a, exposure assessments should cover the general population, as well as critical groups that are vulnerable or are expected to have exposure higher than the general population (e.g. infants, children); _________________ 1a Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials - EFSA Journal 2016;14(1):4357 [28 pp.] https://www.efsa.europa.eu/en/efsajournal /pub/4357
Amendment 36 #
Motion for a resolution Recital F e (new) Fe. whereas according to EFSA, nanotechnology and nanomaterials are a new technological development and FCM are one sector in which the use of nanomaterials has featured; whereas the specific properties of nanomaterials may affect their toxicokinetic and toxicology profiles, but limited information is available in relation to these aspects; whereas there are also uncertainties stemming from the difficulty of characterising, detecting and measuring nanomaterials in food and in biological matrices, and from the limited availability of toxicity data and test methods;
Amendment 37 #
Motion for a resolution Recital F f (new) Ff. whereas labelling is a very direct and effective tool of informing the consumer about the characteristics of a product;
Amendment 38 #
Motion for a resolution Recital F g (new) Fg. whereas a horizontal approach to substances across all economic sectors provides consistency of the legislation and predictability for businesses;
Amendment 39 #
Motion for a resolution Paragraph 1 1. Acknowledges that the Framework Regulation constitutes a
Amendment 4 #
Motion for a resolution Citation 3 a (new) Amendment 40 #
Motion for a resolution Paragraph 1 a (new) 1a. Considers that placing the registration and monitoring of FCM on common foundations will create a far clearer situation; considers, at the same time, that care must be taken to ensure that the increased tasks of the authorities and public expenditure in this connection are proportionate to the aims in view;
Amendment 41 #
Motion for a resolution Paragraph 2 2. Underlines that, while the major focus should be on the adoption of specific measures for those 13 materials not yet regulated at EU level, shortcomings exist
Amendment 42 #
Motion for a resolution Paragraph 2 2. Underlines that, while the major focus should be on the adoption of specific measures for those 13 materials not yet regulated at EU level, all relevant stakeholders point out that shortcomings exist in the implementation and enforcement of the legislation in place;
Amendment 43 #
Motion for a resolution Paragraph 2 a (new) 2a. Proposes, in particular, to revise the existing EU specific measures on ceramics (Council Directive 84/500/EEC)1a with a view to reducing the limits for cadmium and lead release; and to review the implementing measure on plastics materials (Commission Regulation (EU) No 10/2011)1b in light of the current state of knowledge with a view to including provisions for colorants, solvents and all polymer production aids; _________________ 1a OJ L 277, 20.10.1984, p. 12 1b OJ L 12, 15.1.2011, p. 1–89
Amendment 44 #
Motion for a resolution Paragraph 2 a (new) 2a. Underlines, in particular, the need for strengthening the limits for lead and cadmium and include limits for other heavy metals such as cobalt in the revision of Council Directive 84/500/EEC1a on ceramics as proposed by the European Commission in 2013; regrets that the revision of the Directive on ceramics has not been discussed in the European Parliament and within the Member States yet; _________________ 1a OJ L 277, 20.10.1984, p. 12
Amendment 45 #
Motion for a resolution Paragraph 3 3. Awaits the upcoming review by the Commission’s Joint Research Centre of the national provisions adopted by Member States for non-harmonised materials; calls on the Commission to use this review as a starting-point for drawing up the required measures
Amendment 46 #
Motion for a resolution Paragraph 3 3. Awaits the upcoming review by the Commission
Amendment 47 #
Motion for a resolution Paragraph 3 3. A
Amendment 48 #
Motion for a resolution Paragraph 3 a (new) 3a. Urges the Commission, when drawing up the measures required, to take account of the study conducted by the EPRS entitled 'Food Contact Materials - Regulation (EC) 1935/2004 - European Implementation Assessment' and of the national measures which are already in force or are being prepared;
Amendment 49 #
Motion for a resolution Paragraph 3 a (new) 3a. Acknowledges, on the basis of the 2015 Science and Policy Report 1a by the Commission's Joint Research Centre, the issue of heavy metals migrating into food and the release of heavy metals into wastewater; _________________ 1a https://ec.europa.eu/jrc/en/publication/eur -scientific-and-technical-research- reports/scoping-investigations-release- metals-rim-area-decorated-articles- support-revision-ceramic
Amendment 5 #
Motion for a resolution Citation 3 b (new) - having regard to Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 'Living well, within the limits of our planet' which inter alia recognises the need for the EU to address combination effects of chemicals and safety concerns related to endocrine disruptors in all relevant Union legislation1a , _________________ 1a 7th Environmental Action Programme: OJ L 354, 28.12.2013, p. 171–200, http://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX:32013D13 86
Amendment 50 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of the materials referred to on the EU market and the risk they pose to human health, and in order to preserve the single market for food and food packaging alike, the Commission should prioritise the drawing-up of specific EU measures for paper, board, coatings, inks and adhesives; believes that clear EU-level rules for food contact materials should be in line with the broader EU goal to move to a circular economy while taking into account different properties and risks for new and recycled materials;
Amendment 51 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of the materials referred to on the EU market and the risk they pose to human health, the Commission should prioritise the drawing-up of specific EU measures for paper
Amendment 52 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of the materials referred to on the EU market and the risk they pose to human health, the Commission should prioritise the drawing-up of specific EU measures for paper, board, coatings, inks and adhesives; is of the opinion that clear rules at the European level for all food contact materials are vital for a credible transition to a circular economy;
Amendment 53 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of
Amendment 54 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of the materials referred to on the EU market and the risk they pose to human health, and in order to preserve the EU single market for food contact materials and food products alike, the Commission should prioritise the drawing-up of specific EU measures for paper, board, coatings, inks and adhesives;
Amendment 55 #
4.
Amendment 56 #
Motion for a resolution Paragraph 4 4.
Amendment 57 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of the materials referred to on the EU market and the risk they pose to human
Amendment 58 #
Motion for a resolution Paragraph 4 4. Believes that, given the prevalence of the materials referred to on the EU market and the risk they pose to human health, the Commission should prioritise the drawing-up of specific EU measures for paper, board, varnish, coatings, inks and adhesives;
Amendment 59 #
Motion for a resolution Paragraph 4 a (new) 4a. Believes that the absence of specific safety requirements for certain FCMs at the EU level has driven up the costs of compliance, which is often passed on to consumers later in the supply chain; moreover, the lack of harmonized rules has resulted in the introduction of barriers which are disruptive to the functioning of the internal market and have delayed market access for businesses;
Amendment 6 #
Motion for a resolution Citation 3 c (new) Amendment 60 #
Motion for a resolution Paragraph 4 a (new) 4a. Welcomes the fact that members of the public, businesses and interbranch organisations in Member States are advocating a ban on the use of mineral oils in inks for packaging materials throughout the Union; calls on the Commission and Member States to ban this use of mineral oils in inks in the abovementioned specific EU measures;
Amendment 61 #
Motion for a resolution Paragraph 4 a (new) 4a. Underlines that special attention needs to be paid to those food contact materials, whether in contact with food directly or indirectly, with a higher risk of migration, such as materials surrounding liquids and high-fat foods as well as to materials that are in contact with food for a long period of time;
Amendment 62 #
Motion for a resolution Paragraph 4 b (new) 4b. Considers it imperative that Member States should involve all relevant stakeholders in the process, when specific safety requirements for FCMs are proposed;
Amendment 63 #
Motion for a resolution Paragraph 5 5. Is convinced that, in light of the EU’s focus on moving towards a circular economy, specific measures at EU level should also be proposed for recycled paper and board, devoting particular attention to the risk of migration of mineral oils into food pacakged in reused paper and board material; supports, pending a European ban on mineral oils in inks for packaging materials, research into the incorporation of functional barriers in packaging material in order to prevent this migration; supports research into methods of removing mineral oils during recycling of paper and board; supports, pending a European ban on mineral oils in inks for packaging materials, the increasing use by businesses of so-called 'low-migration inks';
Amendment 64 #
Motion for a resolution Paragraph 5 5. Is convinced that
Amendment 65 #
Motion for a resolution Paragraph 5 5. Is convinced that, in light of the EU’s focus on moving towards a circular economy, specific measures at EU level should also be proposed for recycled paper and board; notes that there is a limit to the number of times that recycled paper and board products may be reused, thus requiring a steady supply of fresh wood fibres;
Amendment 66 #
Motion for a resolution Paragraph 5 5. Is convinced that, in light of the EU’s focus on moving towards a circular economy, better synergies between the Framework Regulation on FCMs and the circular economy should be developed, which could include specific measures at EU level
Amendment 67 #
Motion for a resolution Paragraph 5 5. Is convinced that
Amendment 68 #
Motion for a resolution Paragraph 5 5. I
Amendment 69 #
Motion for a resolution Paragraph 5 a (new) 5a. Supports the increase in recycling targets for all materials in the Commission proposal for a Directive amending Directive 94/62/EC on packaging and packaging waste1a, and encourages the European Parliament and the Council to include reuse in these targets; reminds the Commission, however, that targets for recycling and reuse must be accompanied by adequate control measures to ensure the safety of materials entering into contact with foods; _________________ 1a COM(2015) 596 final
Amendment 7 #
Motion for a resolution Citation 5 a (new) - having regard to the Communication from the Commission to the Council on "The combination effects of chemicals - Chemical mixtures"1a, _________________ 1a COM(2012)0252 final
Amendment 70 #
Motion for a resolution Paragraph 5 a (new) 5a. Emphasises the difficult position which small and medium-sized enterprises in the production chain find themselves in, given that, in the absence of relevant legislative provisions, they are not in position to receive or pass on information which would guarantee that their products are safe;
Amendment 71 #
Motion for a resolution Paragraph 5 a (new) 5a. Recalls that paper and board produced from fresh fibre is free of residuals stemming from previous use; argues that this should be taken into account if the Commission is proposing specific measures at EU level concerning paper and board food contact materials;
Amendment 72 #
Motion for a resolution Paragraph 5 a (new) 5a. Believes that both the FCMs Regulation and the circular economy package should consider the safety implications of using FCMs made from recycled products, starting by the phasing out of all hazardous substances;
Amendment 73 #
Motion for a resolution Paragraph 5 a (new) 5a. however, the re-use of materials under the principles of circular economy and resource-efficiency should, in no way, lead to a higher number of contaminants added to the final product.
Amendment 74 #
Motion for a resolution Paragraph 5 b (new) 5b. Emphasises the importance of further scientific research into the interaction between different chemicals (cocktail effect), into non-intentionally added substances (NIAS), into nanomaterials and into the impact of contaminants contained in recycled materials;
Amendment 75 #
Motion for a resolution Paragraph 5 b (new) 5b. Recognises that the current paradigm for evaluation of safety of FCMs is insufficient, as there is a general underestimation of the role of FCMs in food contamination and a lack of information on human exposure;
Amendment 76 #
Motion for a resolution Paragraph 6 6. Is aware of the important role played by the European Food Safety Authority (EFSA) in the risk assessment of substances for use in FCMs regulated by specific measures; recognises the costs involved in the risk assessment of a particular substance and EFSA’s limited resources; calls on the Commission, therefore, to
Amendment 77 #
Motion for a resolution Paragraph 6 6. Is aware of the important role
Amendment 78 #
Motion for a resolution Paragraph 6 6. Is aware of the important role played by the European Food Safety Authority (EFSA) in the risk assessment of substances for use in FCMs regulated by specific measures; recognises the costs involved in the risk assessment of a particular substance and EFSA’s limited resources;
Amendment 79 #
Motion for a resolution Paragraph 6 6. Is aware of the important role played by the European Food Safety Authority (EFSA) in the risk assessment of substances for use in FCMs regulated by specific measures; recognises the costs involved in the risk assessment of a
Amendment 8 #
Motion for a resolution Citation 5 b (new) Amendment 80 #
Motion for a resolution Paragraph 6 6.
Amendment 81 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the EFSA and the European Chemicals Agency (ECHA) to cooperate and coordinate their work more closely in an effort to make effective use of the resources available to carry out comprehensive assessments;
Amendment 82 #
Motion for a resolution Paragraph 7 7. Recognises that in order to properly assess the risks of FCMs, it is necessary to take into account
Amendment 83 #
Motion for a resolution Paragraph 7 7. Recognises that in order to properly assess the risks of FCMs, it is necessary to take into account both substances used in their manufacture and processing and non- intentionally added substances (‘NIAS’), including impurities from the intentionally added substances and other substances resulting from chemical reactions;
Amendment 84 #
Motion for a resolution Paragraph 7 a (new) Amendment 85 #
Motion for a resolution Paragraph 7 a (new) 7a. Calls on EFSA and the Commission to extend the concept of vulnerable groups to pregnant and breastfeeding women and to include the potentials effects of low doses exposure and non monotonic dose-responses in the risk assessment criteria;
Amendment 86 #
Motion for a resolution Paragraph 7 a (new) 7a. Calls on the Commission to study further the approach based on safety checks for pre-manufactured food contact articles or other approval procedures for food contact articles;
Amendment 87 #
Motion for a resolution Paragraph 8 8. Regrets that EFSA, in its current risk assessment procedure, does not take account of the so-called ‘cocktail effect’ or multiple exposures, and urges EFSA to do so in future; also urges the Commission to consider this when determining migration limits that are considered safe for human health; therefore calls on the Commission to require from operators that they assess the health impacts of chemicals used as food contact materials, including genotoxicity, breast tissue development, obesity, and immune systems before and after birth, on both consumers and workers from exposure during production, use, disposal, reuse and recycling;
Amendment 88 #
Motion for a resolution Paragraph 8 8. Regrets that EFSA, in its current risk assessment procedure, does not take
Amendment 89 #
Motion for a resolution Paragraph 8 8. Regrets that EFSA, in its current risk assessment procedure, does not take account of the so-called
Amendment 9 #
Motion for a resolution Citation 5 c (new) - having regard to Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 'Living well, within the limits of our planet' which inter alia recognises the need for the EU to address the combination effects of chemicals and the safety concerns related to endocrine disruptors in all relevant Union legislation1a ; _________________ 1a 7th Environmental Action Programme: OJ L 354, 28.12.2013, p. 171–200, http://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX:32013D13 86
Amendment 90 #
Motion for a resolution Paragraph 8 8.
Amendment 91 #
Motion for a resolution Paragraph 8 8. Regrets that EFSA, in its current risk assessment procedure, does not take account of the so-called ‘cocktail effect’ or multiple exposures, and urges EFSA to do so in future; also urges the Commission to consider this when determining migration limits that are considered safe for human health over long periods as well;
Amendment 92 #
Motion for a resolution Paragraph 8 8. Regrets that EFSA, in its current risk assessment procedure, does not take account of the so-called ‘cocktail effect’ or multiple exposures, and
Amendment 93 #
Motion for a resolution Paragraph 8 a (new) 8a. Calls on the Commission to fill the safety assessment gap between the REACH and FCM legislation by obliging companies to produce safety assessments of the human health aspects of chemicals used in food contact materials, including consumer and worker exposure during production, use, disposal, reuse and recycling; this requirement should be added to Regulation (EC) No 1935/2004;
Amendment 94 #
Motion for a resolution Paragraph 8 a (new) 8a. Further regrets that EFSA does not yet take account of the possibility of deleterious microorganisms in FCMs; therefore urges EFSA´s Panel on Biological Hazards (BIOHAZ) to examine the issue of microorganisms in FCMs through preparation of an EFSA Opinion on the subject;
Amendment 95 #
Motion for a resolution Paragraph 8 a (new) 8a. Notes with concern the increased effect on health substances used in food contact materials can have on babies and young children;
Amendment 96 #
Motion for a resolution Paragraph 8 b (new) 8b. Points out that FCMs are included within the scope of Regulation (EU) No 528/2012 (the Biocidal Products Regulation, "BPR"1a) as biocides may be present in food contact materials to keep their surface free from microbial contamination (disinfectants) and to have a preservative effect on the food (preservatives). However, the different types of biocides in FCMs are regulated under different legal frameworks and, depending on the type of biocide, the risk assessment has to be carried out by ECHA or EFSA or by both agencies; _________________ 1a OJ L 167, 27.6.2012, p. 1–123
Amendment 97 #
Motion for a resolution Paragraph 8 b (new) 8b. Notes that the use of potential endocrine disruptors is of particular concern in food contact materials given their potential to cause harm even at extremely small doses;
Amendment 98 #
Motion for a resolution Paragraph 8 c (new) 8c. Calls on the Commission to ensure the coherence between the Regulations on FCM and biocidal products and to clarify the roles of ECHA and EFSA in this respect; further calls on the Commission to work on a harmonised and consolidated approach for the overall assessment and authorisation of substances used as biocides in FCMs, with a view to avoiding overlapping, legal uncertainties and duplication of work.
Amendment 99 #
Motion for a resolution Paragraph 8 d (new) 8d. Calls on EFSA to consider that food production sites were identified by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in 2009 as one critical place promoting the development of bacteria resistant to both antibiotics and biocides; therefore FCMs containing biocides may also contribute to the occurrence of antibiotic resistant bacteria in humans;
source: 584.109
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History
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2015-12-11Show (1) Changes | Timetravel
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2015-11-01Show (5) Changes
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