PPE DIRECTIVES & APPROVALSCURRENT SITUATION For clarity its important to understand that since 1st January 2021, a CE mark granted by UK Notified Bodies is not recognised by the EU. Since then the PPE EU regulation 2016/425 was translated & ammended into UK Law and is therefore now effective in both the UK and EU. Going forward,to legally sell PPE in the UK & EU, it must be gradually dual certified and therefore dual marked with CE & UKCA marks, under the ammended timetable indicated below. 14/11/2022 On Monday 14th November 2022 the Under Seccratary of State Kevin Hollinrake laid before Parliament the Draft Statutory Instrument Regulations 2022 ammending the UKCA guidance, previously ammended on June 20th 2022. The main changes are: 1 PPE manufacturers can continue to use the CE as a basis for applying UKCA until 31st December 2024 - so this is a further 2 year extension to the date announce in June 2022 2 The easement allowing the affixment of UKCA and importer details via a label or on accompanying documentation has been extended till 31st December 2027 again giving a further 2 year extension 01/06/2022 UKCA Marking will replace all CE Marking for most PPE products that are or will be placed in the UK Market. The date of change for most PPE products is 01 January 2023 and 01 July 2023 for products complying with the Medical Device Directive It is the legal resposibility for the Importer/Distributer to implement changes to comply UKCA legislation. All products listed on our website do/will comply with UKCA legislation prior to 01 January 2023. The current Certification of our products can be directly viewed/downloaded under the Data Sheet link at the bottom of each Product Page. BREXIT CONSIDERATIONS All the European Directives listed below are in force and form part of current UK legislation These Directives in association with the relevant CEN European Product Standards form the basis of all regulation of Personal Protective Equipment and Medical Devices in the EU. However, after the Referendom of 23 June 2016 followed by implementation of Article 50 on 29 March 2017 and susequent extension till 31 October 2019, on the UKs future membership of the EU, the future situation now remains unclear. However the key points to bear in mind at this stage are: All CE rules will continue to apply until we have actually left the Single Market UK influence on the rules will diminish CE marking is integral to the Single Market so we will need to apply the rules if we want to trade with the EU even if UK decides to repeal some of them for internal trade Essential requirements are heavily integrated into our occupational health and safety regime Environmental requirements are the ones most likely to be axed We will continue to keep this site updated as and when new information becomes available PPE DIRECTIVE 89/686/EEC has now been superceded by REGULATION (EU) 2016/425 on Personal Protective Equipment (Effective 21 April 2018) Main changes include: The scope and conclusions are more clearly defined Increased obligations on importers and distributors Product Catergories are defined and some products will change catergory New EC Type Examination Certificates will have maximum validity of 5 years Current EC Type Examination Certificates will need to be reviewed by 21 April 2023 All Producys must meet latest version of relevant standard EC declaration of Conformity (or a Web link) shall accompany each product PPE DIRECTIVE 89/686/EEC (effective 1995) All Personal Protective Equipment (PPE) products sold in the UK must meet the requirements of this Directive Compliance with this Directive is indicated by affixing a CE pictogram The PPE Directive covers a wide range of safety equipment from head to foot The Directive classifies PPE into 3 catergories CATERGORY 1 SIMPLE DESIGN Products offering protection against hazards of minimal risk The manufacturer can self certify products in this catergory Protection against superficial mechanical injury, temperatures not exceeding 50 C and use of chemicals of weak action only eg Washing up gloves CATERGORY 2 INTERMEDIATE DESIGN Products offering protection against hazards that are not covered by Catergory 1 or 3 The manufacturer is required to submit Notified Body for Type testing to an appropriate Standard eg Cut Resistant gloves CATERGORY 3 COMPLEX DESIGN Products offering protection against hazards of serious or mortal risk In addition to submission for Type Testing the Product must be manufactured under an assesed quality management system, to ensure ongoing production meets the level of initial type testing Protection against high & low temp environments <-50C and > 100C Protection against Ionising Radiation Protection against electric shock and live working eg Chemical Resistant gloves Product Standards provide a system of evaluating the performance of a product according to stated levels. Pictograms are defined to provide a means of identifying the performance characteristics and hence its subsequent suitability for the intended application  PPE DIRECTIVE 89/686/EEC June 1995 PPE REGULATION 2016/425 April 2016 (Transition 2 years) MEDICAL DEVICE DIRECTIVE The New Medical Regulation (MDR) EU 2017/745 came into force in the EU (and Northern Ireland due to the provisions in the Exit Agreement) on 26 May 2021.This new Regulation has over 100 additional articles included, mainly to safeguard patient safety, when compared to the old Regulations Following the UK's withdrawal from the EU 2017/745 has not been implemented in the UK Therefore the current UK Medical Device Regulation 2002 is based on the now withdrawn EU 93/42/EEC Directive and has been further ammended with additions to encourage a higher level of Patient safety. This includes strengthened requirements relating to post-market surveillance and Unique Device Indicator, of products MEDICAL DEVICE DIRECTIVE 93/42/EEC (effective 1993) ammended by MEDICAL DEVICE DIRECTIVE 2007/47/EC This is the European Directive for regulating Medical Devices for sale in the UK It is one of a group of 3 Directives that covers all Medical Equipment Compliance with this Directive is also indicated by affixing a CE pictogram Some products will meet both the Medical Device (MD) and Personal Protective Equipment (PPE) Directives Class 1 Low risk eg Latex Examination Glove Class 1m Low risk Class 1s Low risk eg Sterile Latex Examination Gloves Class IIa Medium risk eg Sterile Surgical Glove Class !!b Medium risk Class 3 High risk Class 1 Medical Devices are self regulated and compliance is made through a declaration of conformity All other classes require CE Certification through a Notified Body MD DIRECTIVE 93/42/EEC plus AMMENDMENTS FOOD APPROVAL European Regulation EC 1935/2004 Materials and articles intended to come into contact with food, in their finished state, are regulated by this Directive A wide selection of our product range is food safe; suitable for food contact and therefore can be used in a food preperation environment. The framework of this regulation is to ensure that all all materials coming into contact with food, are tested, to ensure that in normal use, they will not transfer their constituents to food. These constituents could endanger health, cause unacceptable changes to the composition of food or deteriorate its organoleptic properties (Taste. texture, aroma, appearance) Specific labelling requirements are affixed on packaging and products confirming their suitability with food contact. Compliance with this regulation is indicated by affixing a food pictogram European Regulation EC 10/2011 To complete the above General Regulation, specific Directives per material categories have been put into place in order to set the framework of the testing procedures and acceptability levels Food Approval Standards summary PICTOGRAMSDownload the PDF to view a list of the pictograms used in our product range and most commonly found in our industry accompanied with a short description. A summary of logos will usually be printed on inners and/or outer packs of our products. |