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:

USADisinfectants/sanitizers

EUDisinfectants/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.

One registration authority OPP, EPA Numerous 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-useOnly 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 list AI 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.

USADisinfectants/sanitizers

EUDisinfectants/sanitizers

Product type/use category BEL

DEN FR[ii]

GER

GR IRE NL POR

SWE SWI UK

USA[iii]

EU

1. Public health disinfectants & sanitizers

A A[iv]   note[v]

A N     A[vi] A   A  

2. Personal health care disinfectants

      A[vii]

A[viii]

N   A[ix]

None A   A A[x]

3. Non public health (private) disinfectants/sanitizers/ bacteriostats

A     notev

A N A[xi]

  A[xii] A   A  

4. Veterinary area and domestic animal disinfection

A A   A[xiii]

A[xiv]

N   A[xv]

None A      

5. Food/feed area disinfectants

A A[xvi]

A[xvii]

None

A N   A[xviii]

None A   A  

6. Drinking water disinfectants

A A[xix]

  None

A N   A[xx]

A A   A  

From an OECD Report: Survey of OECD Member Countries' Approaches to the Regulation of Biocides, 99.

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.