Product Certification

Food and Drug Administration & EC ResAP (2004)3

The Purolite Romanian manufacturing facility is US-FDA inspected for the production and distribution of APIs. Products used in food and beverage consumption comply with ResAP (2004)3 and/or FDA 173.25 and 173.65 regulations.

Establishment Inspection Report
Establishment Registration Renewal Certificate
Current Good Manufacturing Practice Certificate
Resolution ResAP (2004)3
FDA 173.25 Ion Exchange Resins
FDA 173.65 Adsorbents 
FDA Status for Chromalite Products Adsorbent Resins
FDA Status for Chromalite Products Strong Acid Cations
FDA Status for Chromalite Products Base Anion Resins
 

Japanese Pharmaceutical and Medical Devices Agency

The Japanese authority, Pharmaceutical and Medical Devices Agency (PMDA), is equivalent to the FDA in the United States of America. PMDA issues certificates of accreditation of API manufacturers (GMP compliance).

Certificate of Accreditation of API Manufacturers 

French Health Ministry Approval

Download the French Health Ministry Certificates of Approval for Potable Water Treatment with Purolite products.
C100E Agreement
C100E Avis AFSSA
C100FMK9130 Agreement
C100FMK9130 Avis AFSSA
Purolite A520E | PFA520E | PPA520E
Purolite C107E
Purolite C120E | PFC120E
 

Halal Certification

Purolite produces Halal products under the supervision of several respected Islamic Councils. For the specific Halal certificate for each plant, please click on the links below.

China  |  Romania  | United States

The Indonesian Council of Ulama, has also declared the China manufacturing plant to be Halal certified. Download the MUI certification for the China facility.

China

Kosher Certification

Purolite manufactures products in compliance with kosher production and packaging rules. Visit Kosher Certification and search Purolite for a complete list of our kosher-certified products.

NSF/ANSI Certifications

Visit the Water Quality Association for a list of products that have been certified to NSF/ANSI-44 Standards and NSF/ANSI-61 Standards.

Download the NSF/ANSI WQA Gold Seal Certificate of Compliance for each manufacturing plant.

China  |  Romania  | United States

United Kingdom Secretary of State Approval

Visit the UK Drinking Water Inspectorate for a list of approved Purolite products for drinking water in the United Kingdom.  

Water Regulations Advisory Scheme (WRAS) Approval8

The WRAS (Water Regulations Advisory Scheme) tests water products to ensure that they do not waste, misuse, unduly consume or contaminate the water supply. The following Purolite products have been aproved by WRAS in the United Kingdom:

A502PS
A520E
A600E/9149
A860S
C100E-LT
C104EPlus
C104E/5264
C107E
FerrIX™ A33E
Hypersol-Macronet® MN200
PFC100E
S108

TSE/BSE

All manufacturing and packaging equipment, raw materials and processing aids used in producing the below Purolite enzyme carriers comply with Annex IIIa of Directive 2000/13/EC, amended by Directive 2007/68/EC and are free from Transmissible Animal Spongiform Encephalopathy (TSE/BSE) or Genetically Modified Organisms(GMO) or Allergens.

Vew Products

Regulatory Information

Regulatory expertise throughout the product life-cycle is essential to identify regulatory options for product development, optimize ‘speed to market’ and produce a product that meets customer needs.

View our Regulatory Information brochure for information on existing regulatory approvals.