New EU Regulations Mean Changes to PPE Legislation
Regulation 425/2016/EU was approved on March 9, 2016, and published in the Official Journal of the European Union on March 31, 2016. The directive will come into effect on April 21, 2018.
The acceptance of Regulation 425/2016/EU has resulted in a number of key changes for manufacturers of PPE. The Key changes relate to:
• EC Type examination certificates will be renamed EU Type examination certificates, issued under Module B in Annex V. These will remain valid until April 21, 2023, unless they expire before that date.
• Renewal of EU Type examination certificates should be submitted between 12 months and six months before the expiration date. SGS can advise on renewal depending on the product.
• A re-specification of technical file (Annex III) requirements.
• Categories I and III definitions have been refined:
Category I now includes protection against several minimal risks
Category III now exclusively includes risks that may cause very serious consequences, consequences such as death or irreversible damage to health.
Category II, as above, contains products not included in Category I or III.
• In a new section entitled, ‘Obligations of Manufacturers’, the legislation unambiguously outlines the responsibilities of makers of PPE products.
SGS provides a one-stop solution for companies working in the PPE sector. SGS can advise companies on how the changes in PPE legislation affect their business. In addition, their accredited laboratories can assist with testing, certification, and compiling technical files to help manufacturers remain compliant.
SGS Personal Protective Equipment (PPE) Services
SGS’s global network and experts provide a one-stop simple solution for PPE product compliance. Our accredited laboratories can satisfy all testing and certification requirements and provide assistance in compiling technical files and coordinate with Notified Bodies for application of EC type examination. Learn more about SGS’s Personal Protective Equipment (PPE) Services (www.sgs.com/en/consumer-goods-retail/softlines-and-accessories/personal-protective-equipment-ppe?dc=http&lb=)
SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full Regulation (EU) 2016/425 Personal Protective Equipment SafeGuardS. (www.sgs.com/en/news/2016/05/safeguards-10016-regulation-eu-2016-425-personal-protective-equipment)
To receive SGS SafeGuardS direct to your inbox, subscribe here: www.sgs./com/subscribesg.
For further information contact:
Tel: +44 (0)1934 522917 Option 4
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.
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