See appendix 1

Product definition

Article. These products are not classified as hazardous according to REACH Regulation 1907/2006, or European CLP/GHS Regulation 1272/2008.

Signal word

No signal word.

Hazard statements

No known significant effects or critical hazards.

Special packaging requirements

None. ____________________________________________________________________________________ SECTION 3 - Materials of Construction The products detailed in Section 1 are comprised of the following materials: PF30 Filter Assemblies Material Name Product codes CAS Number Styrene Butadiene Copolymer housing All codes 9003-55-8 Polypropylene mesh All codes 9003-07-0 Polycarbonate and EVA end caps All codes 25037-45-0 and 24937-78-8 Polypropylene mesh support All codes 9003-07-0 Other components Material Name Product codes CAS Number EVA and Acetal nose clip PF30-KIT1, PF30-KIT3 24937-78-8 and 9002-81-7 Polypropylene mouthpiece PF30-KIT2 9003-07-0 TPE mouthpiece MPE1, PF30-KIT1, PF30- Supplier proprietary KIT3 information These products are not known to contain BADGE, NOGE, or BFDGE. Trace additives will be present in the plastic components. There are no additional ingredients present which, within the current knowledge of the supplier, are classified and contribute to the classification of the article. There are no current SVHC substances known to be present in the finished articles above 0.1%. There are no current ROHS2 Directive (2011/65/EU) and amendment (2015/863) substances of concern (including Lead, Cadmium, Mercury, Hexavalent Chromium, Polybrominated biphenyl (PBB), Polybrominated diphenyl ether (PBDE), Bis(2-ethylhexyl) phthalate (DEHP), Benzyl Butyl Phthalate (BBP), Dibutyl phthalate (DBP) and Di-isobutyl phthalate (DIBP)) known to be present in the materials employed in excess of the limits laid down, based on information from our suppliers and knowledge of substances used within Pall the manufacturing facility. Pall Medical filters do not employ natural rubber latex, or latex derivatives in their construction. Pall Medical products do not knowingly contain materials of direct animal origin i.e. animal parts, tissues, or body fluids however, to assist our customers in performing a TSE/BSE risk assessment, we are pleased to provide the following information: Certain plastics are known to contain trace levels of additive (e.g. calcium stearate) which are manufactured from tallow. Pall Medical products may utilize components in the fluid pathway which are fabricated from plastic resins containing tallow-derived additives at trace levels, but Pall does not test for them. Please be advised that bovine tallow-derived additives are not considered specified TSE/BSE risk materials according to the current revision of the U.S. Code of Federal Regulations, Title 21 of part 189.5, which defines specified risk material for human food and Regulation (EU) 722/2012 concerning medical devices manufactured using tissues of animal origin, in Article 4, specifically excludes tallow derivatives provided they have been processed under conditions at least as rigorous as those stated in Section 3 of Annex 1 as shown below: • Trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (glycerol, fatty acids and fatty acid esters production), • Saponification with NaOH 12 M (glycerol and soap production) • Batch process: at not less than 95 °C for not less than 3 hours, • Continuous process: at not less than 140 °C, under pressure for not less than 8 minutes or equivalent, • Distillation at 200 °C. The plastics raw materials we purchase have been processed with one of these steps. Pall continuously works to assure the safety of our products with respect to potential BSE/TSE transmission by working through our supply chain to obtain information regarding the possible use of animal-based material and to confirm specific sourcing and processing details where applicable _____________________________________________________________________________________