- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (31/12/2020)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Regulation (EU) 2017/1000 of 13 June 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related substances (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
Point in time view as at 31/12/2020.
There are currently no known outstanding effects for the Commission Regulation (EU) 2017/1000.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
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(1), and in particular Article 68(1) thereof,
Whereas:
(1) Perfluorooctanoic acid (‘PFOA’), its salts and PFOA-related substances(2) have some specific properties such as high friction resistance, dielectricality, resistance to heat and chemical agents, and low surface energy. They are used in a wide variety of applications such as in the fluoropolymer and fluoroelastomer production, as surfactants in fire-fighting foams, and in textile and paper production to provide water, grease, oil and/or dirt repellency.
(2) On 14 June 2013, the Member State Committee, referred to in Article 76(1)(e) of Regulation (EC) No 1907/2006, identified PFOA as a persistent, bioaccumulative and toxic substance (‘PBT’) in accordance with Article 57(d) of that Regulation. On 20 June 2013, PFOA was included in the Candidate List of Substances of Very High Concern (‘SVHC’) for possible inclusion in Annex XIV to Regulation (EC) No 1907/2006.
(3) On 17 October 2014, Germany and Norway submitted to the European Chemicals Agency (‘the Agency’) a dossier(3) pursuant to Article 69(4) of Regulation (EC) No 1907/2006 (‘the Annex XV dossier’), proposing to restrict the manufacture, placing on the market and use of PFOA, its salts and PFOA-related substances, in order to address the risks to human health and the environment. Germany and Norway proposed a concentration limit of 2 ppb for the presence of these substances in other substances, mixtures or articles, and did not propose exemptions except for second-hand articles for which an end-use in the Union can be demonstrated before the date of application of the restriction.
(4) On 8 September 2015, the Agency's Committee for Risk Assessment (‘RAC’) adopted its opinion concluding that subject to modification of the scope and conditions proposed in the Annex XV dossier, a general restriction on manufacture, use and placing on the market of PFOA, its salts and PFOA-related substances, is the most appropriate Union-wide measure to address the identified risks in terms of effectiveness in reducing those risks. RAC proposed two different concentration limits, namely 25 ppb for PFOA and its salts and 1 000 ppb for one or a combination of PFOA-related substances, in other substances, mixtures or articles, reflecting the possible presence of unavoidable impurities and unintended contaminants, and taking account of the capabilities of analytical methods. RAC proposed to exempt from the restriction photographic coatings applied to films, papers or printing plates, implantable medical devices and substances or mixtures used in semiconductor and photolithography processes, considering the relatively low environmental impact and long substitution timeframes. RAC also proposed to exempt the use of substances as transported isolated intermediates in order to allow the manufacture of alternatives, as well as the placing on the market of second-hand articles.
(5) On 4 December 2015, the Agency's Committee for Socio-Economic Analysis (‘SEAC’) adopted its opinion, indicating that the restriction proposed in the Annex XV dossier, as modified by RAC and SEAC, is the most appropriate Union-wide measure to address the identified risks in terms of its socioeconomic benefits and socioeconomic costs.
(6) SEAC agreed with the exemptions proposed by RAC. In addition, SEAC suggested a three year deferral of the restriction, instead of the eighteen months proposed in the Annex XV dossier, to allow stakeholders to take the necessary compliance measures. Based on socioeconomic considerations, such as high costs, significant economic burden, lack of alternatives, relatively low emissions to the environment, critical uses with high societal benefits, SEAC suggested longer deferrals of the restriction for latex printing inks, textiles for the protection of workers, membranes intended for medical textiles, filtration in water treatment, production processes, and effluent treatment, certain plasma nano-coatings and non-implantable medical devices.
(7) SEAC also suggested to exempt from the proposed restriction fire-fighting foams already placed on the market before the date of application of the restriction, and semiconductor manufacturing equipment.
(8) The Agency's Forum for Exchange of Information on Enforcement, referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted during the restriction process and its opinion has been taken into account.
(9) On 12 January 2016, the Agency submitted the opinions of the RAC and the SEAC(4) to the Commission.
(10) Based on those opinions, the Commission concluded that an unacceptable risk to human health and the environment arises from the manufacture, use or placing on the market of PFOA, its salts and PFOA-related substances on their own, as a constituent of other substances, in mixtures and in articles. The Commission considers that those risks need to be addressed on a Union wide basis.
(11) Perfluorooctane sulfonic acid (‘PFOS’) and its derivatives should be exempted from the proposed restriction, since those substances are already regulated by Regulation (EC) No 850/2004 of the European Parliament and of the Council(5). The unavoidable production of PFOA during the manufacture of fluorochemicals with a carbon chain equal to or shorter than six atoms should also be exempted from the proposed restriction.
(12) As advised by SEAC, the application of the restriction should be deferred generally for a period of three years and for longer periods in relation to specified sectors in order to enable stakeholders to comply with the proposed restriction. While a standard analytical method is available for the determination of extractable PFOS in coated and impregnated solid articles, liquids and firefighting foams (CEN/TS 15968:2010), which most likely can be adjusted to also include PFOA and PFOA-related substances with a relevant detection limit, at present no such standard method is available for extraction and chemical analysis of those substances. The deferral period for the restriction should allow the further development of suitable analytical methods that can be applied to all matrices.
(13) Regulation (EC) No 1907/2006 should therefore be amended accordingly.
(14) The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,
HAS ADOPTED THIS REGULATION:
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 June 2017.
For the Commission
The President
Jean-Claude Juncker
In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:
PFOA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to PFOA.
http://echa.europa.eu/documents/10162/e9cddee6-3164-473d-b590-8fcf9caa50e7
https://echa.europa.eu/documents/10162/2f0dfce0-3dcf-4398-8d6b-2e59c86446be
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Pwynt Penodol mewn Amser: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys