NSF Steering Committee Presentation Mike Paulson NCH International September 2002

European approvals for Disinfectants and sanitizers

“ 5.5 Antimicrobical Agents Products shall be registered by the U.S. Environmental Protection Agency for use in food establishments and adequate documentation of that registration, including registered EPA labels shall be provided to NSF for review. ’’ Current NSF Registration Quidelines:

USA Disinfectants/sanitizers EU Disinfectants/sanitizers Included in all pesticide law, FIFRA, 1972 “Biocide: not commonly used, law refers to insecticides, rodenticides, piscicides, or vertebrate animal repellants, or to antimicrobial pesticides. Separate law for just biocides Biocidal Products Directive (98/8/EC) Became active May 2000, covering 23 different product types. These include disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels. product types One registration authority OPP, EPANumerous National competent authorities Formalized data requirements for AI and end- use products by category Core formalized data for AI common to all categories, then varies by end-use. Same efficacy data for AI and end-use Only Public heath products reviewed Efficacy data of all AI but varies for end-use. Reviews depend on authority. See table II Dose/efficacy relationships for both AI and End-use Dose/efficacy relationships for End-use Comparison of European and USA Disinfectant Registration Requirements

EU and USA Disinfectant Reg Requirements AI must be on a positive approved listAI must be on positive approved list, building list now, data completion up to 10 years. Test requirements: AOAC use dilution and germicidal methods where sixty carriers are tested on each of three samples, representing 3 batches. Must “kill” 59 out of 60 carriers. Test strains are Salmonella choleraesuis (ATCC 10708) Staphylococcus aureus (ATCC 6538) Supplemental Recommendations have been issued to cover hard water, soil loading and re-use. Test requirements; EN1276 (bacteria)and EN1650 (fungi), quantitative suspension tests for the evaluation of microbiocidal activity. The standard determine the concentrations of disinfectant that possess bactericidal activity to achieve a 5 log reduction in viable count of the test organism, the fungicidal tests is a 4 log reduction. Test procedures already address hard water and allow for test modification for specific user reguirments, such organic soil loading, clean and dirty conditions. The test strains are Pseudomonas aeruginosa (ATCC 15442), Escherichia coli ( ATCC 10536), Staphylococcus aureus (ATCC 6538) and Enterococcus hirae (ATCC 10541). Candida albicans and Aspergillus niger are used for the fungal test. The active ingredients and end use products are subject to the same requirements for registration and labeling for all states. The EU Biocide Directive will harmonize the national authorization schemes for biocidal products, with these authorizations being mutually recognized in all Member States. Labeling can still vary by language and local regulation. USA Disinfectants/sanitizers EU Disinfectants/sanitizers

Product type/use categoryBE L DENFR [ii] [ii] GE R GRIRENLPO R SWESWIUKUK USA[ii i][ii i] EU 1.Public health disinfectants & sanitizers AA[iv][iv] note [v] [v] AN A[vi][vi]A A 2.Personal health care disinfectants A[vi i][vi i] A[vii i][vii i] N A[ix ][ix ] NoneA AA[x ][x ] 3.Non public health (private) disinfectants/sanitizers/ bacteriostats A note v ANA[ xi][ xi] A[xii][xii]A A 4.Veterinary area and domestic animal disinfection AA A[xi ii][xi ii] A[xiv ][xiv ] N A[x v][x v] NoneA 5.Food/feed area disinfectants AA[xvi ][xvi ] A[x vii][x vii] Non e AN A[x viii][x viii] NoneA A 6.Drinking water disinfectants AA[xix ][xix ] Non e AN A[x x][x x] AA A [xxi] From an OECD Report: Survey of OECD Member Countries' Approaches to the Regulation of Biocides, 99.Survey of OECD Member Countries' Approaches to the Regulation of Biocides A A A A A

Resistance All 23 biocide product types as categorised by EU (see table 1, annex 1).. The applicant must submit sufficient efficacy data to substantiate the label claim against the target organism/s in the normal conditions of use. The principles for an harmonized evaluation of the dossiers and decision taken for the authorization of a biocidal product by member states are provided by annex VI to the directive, the common principles. A technical guidance document aimed to amplify and explain the common principles is under preparation. This document will give practical guidance, between other things, in assessing risks, effectiveness and unacceptable effects like, for example, resistance.

Proposal Allow country(region) specific biocide registration to qualify a disinfectant / sanitizer for NSF listing as long as all other NSF requirements are met.