10 Amendments of Soledad CABEZÓN RUIZ related to 2018/0081(COD)
Amendment 15 #
Proposal for a directive
Recital 17
Recital 17
(17) Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. It is a local acting genotoxic carcinogen. It is possible, oOn the basis of the available information, including scientific and technical data, the concentrations of formaldehyde used in healthcare are minimal in comparison with those used in industry, and it is possible to set a long and short term limit value for that carcinogen. Formaldehyde is also a contact allergen to the skin (skin sensitiser). It is therefore appropriate to establish a limit value for formaldehyde and to assign a notation for skin sensitisation. In addition, upon request of the Commission, ECHA is also gathering existing information to assess the potential exposure from formaldehyde and formaldehyde releasers at the workplace, including industrial and professional uses48. __________________ 48 https://echa.europa.eu/documents/10162/13 641/formaldehyde_cion_reqst_axvdossier_ en.pdf/11d4a99a7210-839a-921d- 1a9a4129e93e
Amendment 16 #
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17a) Formaldehyde is routinely used in European healthcare centres for the standardised fixation of tissue samples; a pathologist’s diagnosis of a variety of diseases, including cancer, is based on the recognition of microscopic traces in tissue fixed in formaldehyde.
Amendment 17 #
Proposal for a directive
Recital 17 b (new)
Recital 17 b (new)
(17b) Until such time as other fixatives are available in the EU that are able to perform the crucial role that formaldehyde plays in patient care, the healthcare sector should be exempt from any restrictions on formaldehyde use that could give rise to multiple errors in diagnosis, putting countless European patients at risk.
Amendment 18 #
Proposal for a directive
Recital 17 c (new)
Recital 17 c (new)
(17c) Healthcare centres in the EU should take all appropriate measures to keep formaldehyde exposure among their staff within safe limits.
Amendment 23 #
Proposal for a directive
Recital 23
Recital 23
(23) In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings and healthcare facilities. Member States are therefore invited to assess the impact of their transposition act on SMEs in order to make sure that SMEs are not disproportionately affected, with – paying specific attention forto micro-enterprises and forthe administrative burden, – and to publish the results of such assessments.
Amendment 68 #
Proposal for a directive
Recital 17
Recital 17
(17) Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. It is a local acting genotoxic carcinogen. It is possible, oOn the basis of the available information, including scientific and technical data, the concentrations of formaldehyde used in healthcare are minimal in comparison with those used in industry, and it is possible to set a long and short term limit value for that carcinogen. Formaldehyde is also a contact allergen to the skin (skin sensitiser). It is therefore appropriate to establish a limit value for formaldehyde and to assign a notation for skin sensitisation. In addition, upon request of the Commission, ECHA is also gathering existing information to assess the potential exposure from formaldehyde and formaldehyde releasers at the workplace including industrial and professional uses48. __________________ 48 https://echa.europa.eu/documents/10162/13 641/formaldehyde_cion_reqst_axvdossier_ en.pdf/11d4a99a-7210-839a-921d- 1a9a4129e93e
Amendment 70 #
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17a) Formaldehyde is routinely used in European healthcare centres for the standardised fixation of tissue samples; a pathologist’s diagnosis of a variety of diseases, including cancer, is based on the recognition of microscopic traces in tissue fixed in formaldehyde.
Amendment 71 #
Proposal for a directive
Recital 17 b (new)
Recital 17 b (new)
(17b) Until such time as other fixatives are available in the EU that are able to perform the crucial role that formaldehyde plays in patient care, the healthcare sector should be exempt from any restrictions on formaldehyde use that could give rise to multiple errors in diagnosis, putting countless European patients at risk.
Amendment 72 #
Proposal for a directive
Recital 17 c (new)
Recital 17 c (new)
(17c) Healthcare centres in the EU should take all appropriate measures to keep formaldehyde exposure among their staff within safe limits.
Amendment 77 #
Proposal for a directive
Recital 23
Recital 23
(23) In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings and healthcare facilities. Member States are therefore invited to assess the impact of their transposition act on SMEs in order to make sure that SMEs are not disproportionately affected, with specific attention for micro-enterprises and for administrative burden, and to publish the results of such assessments.