As of 21 April 2018, Directive 89/686/EEC will be repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment. The new PPE Regulation is aligned to the New Legislative Framework policy. In addition, it slightly modifies the scope and the risk categorisation of products. It also clarifies the documentary obligations of economic operators. The Commission organised a workshop on the transition from Directive 89/686/EEC to Regulation (EU) 2016/425. This took place on 16 November 2016 in Brussels.

1. NEW PPE REGULATION (EU) 2016/425
SETH MEDICAL AND SAFETY EQUIPMENTS (PVT) LIMITED

2. PPE REGULATION 2016/425 – WHAT’S NEW
 (Published on 31st March 2016 and will come in to force on April 21, 2018.)
• EC Type Examination Certificate validity fixed at 5 years
• Manufacturer have to submit applications for re-certification at earliest 12 months or at least 6 months before certificate expiry.
• Whoever sells PPE under his brand name (Own Brander) will be considered as “Manufacturer” as per PPE Legislation
• Manufacturer has to keep Technical file for 10 years after placement in the market
• Technical Documentation must include Risk analysis for which PPE is intended for use
• Specific use of the glove shall be mentioned in technical documentation.
• EU declaration of conformity shall either be in the packing or a reference of the website shall be given in UI sheet where it can be
found
• Batch / serial number or other element of identification on PPE
• PPE Subject to ageing (month of mfg, Obsolescence, no. of wash cycles) on each PPE
• Authorized representative should be appointed by written mandate.

3. HARMONIZED STANDARDS– WHAT’S NEW
EN388 – Mechanical (Published Nov 2016) EN374 – Chemical
• UoM is mandatory
• Conditioning redefined. (Start within 5 min – complete in 15 min)
• 180 Grit abradent added.
• Clamping of Abrasion different for material thicker than 1.2 mm
• Clarity on the definition of break through in Abrasion
• At each examination at specified level clean the specimen with compressed air
• Concept of “dulling effect” in coup test added (3 times standard canvas result)
• EN ISO 13997 cut test will be done where dulling effect is observed.
• 6 levels (A-2N, B-5N, C-10N, D-15N, E-22N, F-30N)
• Calibration of canvas introduced (Wt. loss 100 cycles b/w 0.009-0.027 gm.)
• Canvas thickness also changed from 1.2-1.35 to 1.0±0.1 mm
• Impact protection added: 5J impact energy under ISO 13594.
• Old: 4343 New: 434XDKP
• EN374-1 - 18 chemicals (6 additional), requirement for mechanical
testing removed – not published
• Type A: (6 Chemicals- 30min), Type B: (3 Chemicals-30 min), Type C
(1 Chemical, 10min)
• EN 374-2:2013 (penetration) Water/ Air leak test has no technical
changes.
• EN374-3 will be withdrawn and published as EN 16523 Part 1-
Permeation. No technical change. Anticipated 2017.
• EN 374-4:2014 Degradation is published. Degradation tests Shall
be carried out on each chemical tested.
• EN 374-5, Micro Organism – Air/Water leak (Bacteria, Fungi) ISO
16604-protection against VIRUSES. Anticipated 2017
EN407 – Heat & EN511 – Cold EN420 – Protective Gloves General Requirements
• No Change
• Manufacturer must divulge all known substances in glove which may cause
allergies. PrEN16778:2014 (Determination of Dimethylformamide in glove
materials) applicable to all PU coated gloves and testing has to be done.
• ISO 21420 will replace EN420 in March 2017
• No provision of minimum length and fit for special purpose.
• Obsolescence determined for the first time
• Reference of consumables must with reports

4. OTHER REGULATIONS
REACH Regulations – EC 1907/2006 Biocide Regulations – EU528/2012
• Candidate list of Substances of Very High Concern (SVHC) shall not exceed 0.1%
W/W in an article.
• “Non-Community Manufacturer” or supplier who is exporting has no responsibilities
under REACH.
• Non-Community Manufacturers cannot themselves register a substance. They can
nominate an “only representative” established within EU.
• SVHC list updated every six months
• Contract with Intertek… Intertek testing SOP
• Homogenized components court decision
• Any Product which is placed into the market after September 1,
2013 which is treated with any biocide (Antibacterial agent) shall
be labelled indicating that the product contains biocide product
and the name of active ingredient. Zinc Pyrithione is a biocide
active ingredient and need to be declared. Sanitized AG is offering
standard labels with biocide information on it.
California Prop65 EU-10/2011 Food Regulations
• California specific law
• List of banned chemicals are tested for compliance. There is no certification, just
assurance based on test report.
• List contains Carcinogens, Mutagens, toxins and allergens.
• Testing done on migration for 6 simulants.
• If there is no specific migration limit then 60mg/Kg limit apply
• Overall migration limit of 10 mg/dm2
• Use of Food Pictogram is not legal
FDA – Food and Drug Act- 21CFR Part 170-199 CFIA – Canadian Food Inspection Agency
• Migration Testing can support but is not mandatory
• This is self assessment / declaration based on confirmation from suppliers
• List of banned chemicals available.
• Manufacturer has to share all contact numbers and addresses of all
suppliers along with percent composition
• The agency contacts suppliers directly for information regarding
use of banned chemicals. Agency also performs its own tests

5. OTHER CONSTRAINTS
Silicones – Organic Polysiloxanes
• Organic silicone polymers when come in contact with a surface, make marks / prints on that surface (especially Glass). As a result
when that part is painted, finger prints appear on the paint because of silicone contact.
• Silicon in its elemental form neither marks the glass nor disturbs the paint. Glass itself is made up of silicates which contains
silicon.
• Except PU and PVC coatings all other coatings are silicone free.
• Spandex is not free from silicone.

6. Under Code of Federal Regulations (CFR) title 21, FDA regulations consists of Part 170 to 199.
Part 191 to 199 are empty and reserved for future. Most of our raw materials fall under following
part numbers.
21 CFR Part 175.105 Substances to be used as components of Adhesives and coatings
21 CFR Part 175.300 Resinous and polymeric coatings (Latex and Chemicals)
21 CFR Part 176.170 Components of paper and paper board in contact with aqueous and
fatty foods
21 CFR Part 176.180 Components of paper and paper board in contact with dry food
(Adhesives)
21 CFR Part 176.200 De-foaming agents used in coatings
21 CFR Part 177.1500 Indirect food additives: Nylon Resins
21 CFR Part 177.1520 Indirect food additives: Olefin Polymers (Dyneema)
21 CFR Part 177.1630 Indirect food additives: Polyethylene phthalate Polymers (Polyester)
21 CFR Part 177.1680 Indirect food additives: Polyurethane Resins
21 CFR Part 177.2430 Indirect food additives: Polyether resins, Chlorinated (Spandex)
21 CFR Part 177.2600 Rubber articles intended for repeated use (Latex and Chemicals)
21 CFR Part 177.2800 Textiles and Textile fibers (Cotton, Rayon, Polyester)
FDA Regulations

7. Contact us.
SETH MEDICAL AND SAFETY PRODUCTS (PVT) LIMITED, SRI LANKA.
- +94772009477 / +94773687864 / +94777387864
- safetysethp@gmail.com.
- http://www.sethsafety.com.