Evaluation criteria of cleaning, disinfection and hygiene products in the Input List for Organic Agriculture and the Input List for Organic Processing

Evaluation criteria of cleaning, disinfection
and hygiene products in the Input List for
Organic Agriculture and the Input List for
Organic Processing

First edition: 16.12.2016
Revised: 22.03.2019 (Leopold, J.; Milan, M.)
 31.10.2018 (Leopold, J.; Milan, M.)

Research Institute of Organic Agriculture (FiBL) | P.O. Box 90 01 63 | D-60441 Frankfurt am Main
Tel. +49 69 7137699-0 | Fax +49 69 7137699-9 | info.deutschland@fibl.org | www.fibl.org

Content

1. Introduction .............................................................................................................. 2
2. Scope of application ................................................................................................ 2
3. Administrative requirements................................................................................. 3
4. Criteria for registration ........................................................................................... 3
4.1 Ingredients ................................................................................................................. 3
 4.1.1 Active ingredients for products for cleaning and disinfection of ........................
 buildings and installations for animal production ............................................... 3
 4.1.2 Negative list ............................................................................................................... 3
4.2 Criteria concerning ecotoxicity and biodegradability .......................................... 4
 4.2.1 Calculation of the critical dilution volume (CDV) ................................................ 5
 4.2.2 Maximum limits for the CDV value ....................................................................... 5
 4.2.3 Calculation example for the critical dilution volume (CDV) .............................. 5
4.3 Other excluded substances ...................................................................................... 6

1. Introduction
Annex VII of Reg. 889/2008 contains a list of substances allowed for use in buildings and
installations for livestock production and in aquaculture. For cleaning and disinfection of
teats and milking equipment, Annex VII of Reg. 889/2008 makes no restrictions.

For the evaluation of cleaning, disinfection and hygiene products a negative list of
substances has been drawn up. These substances are not permitted in cleaning and
disinfection products (C&D products) due to their toxicity and environmental impact. For
the technical justification of the classification, appropriate substance descriptions were
prepared within the framework of a scientific project for the processing sector.
Manufacturers/marketers of C&D products must ensure that these unauthorized substances
(e.g. non-degradable quaternary ammonium compounds) are not present in the product
and secure this statement by suitable measures (e.g. analysis).

The examination of the degradability of the products based on OECD tests is nowadays
only carried out by a few manufacturers. OECD tests are therefore no longer suitable as the
only criteria for the inclusion of products in the input list. With regard to the assessment of
ecotoxicity and degradability, the system of the EU Ecolabel is therefore used
(http://www.eu-ecolabel.de) (exception: udder hygiene and udder care products).

2. Scope of application
These criteria apply to the organic input list for organic processing in Germany from the
2017 edition onwards. They are also applicable for cleaning and disinfection products for
milking equipment as well as products for cleaning and disinfection of buildings and
installations for animal production. In the future, these criteria should also be used for the
evaluation of products for plant production (greenhouses, farm storage, etc.). With the
 Evaluation criteria of cleaning, disinfection and hygiene products in the
 Input List for Organic Agriculture and the Input List for Organic Processing
 Page2
 FiBL Projekte GmbH Review March 2019

exception of point 4.2 "Criteria concerning ecotoxocity and degradability", the criteria also
apply to udder hygiene and udder care products. Therefore the critical dilution volume
(CDV) is not relevant for the approval of udder hygiene and udder care products. Instead
hazard statements (H-statements) as defined in point 4.3 will be applied.

3. Administrative requirements
 • The following applies to all C&D product categories: The full formulation has to be
 submitted (100%).
 • For products that are subject to registration under the Biocidal Products Registration
 Regulation (Biozidmeldeverordnung) an official authorization document (e.g. copy of
 the BAuA registration) has to be submitted.
 • A proof of effectiveness is not required.
 • Listings according to DVG, IHO, DLG or others are displayed in the list, if available.

4. Criteria for registration
4.1 Ingredients

In principle, all ingredients are approved for all applications unless they are on the negative
list (Section 4.2.1). For application areas regulated in the EU Organic Regulation, the
requirements listed there apply.

4.1.1 Active ingredients for products for cleaning and disinfection
 of buildings and installations for animal production
Active ingredients in products for cleaning and disinfection of buildings and installations
for animal production have to comply with the EU Organic Regulation 889/2008 Annex VII.

4.1.2 Negative list

The following substances are not permitted:

 Tensides • Alkylphenolethoxylate (APEO)
 • Fluorosurfactants
 • Quaternary ammonium compounds (QAC´s)
 Acids (incl. their salts) • Phosphoric acid (previously permitted as acid for the
 disinfection of milking equipment, should be excluded
 in the long-term due to eutrophication of aquatic
 environments. For all areas of application, transitional
 periods will apply until the end of 2020)
 • Phosphates
 • Phosphoric acid esters

 Evaluation criteria of cleaning, disinfection and hygiene products in the
 Input List for Organic Agriculture and the Input List for Organic Processing
 Page3
 FiBL Projekte GmbH Review March 2019

• Phosphonic acid (exception: up to max. 1 % permitted as
 stabilizer for peracetic acid and hydrogen peroxide with
 a transitional period until 31.12.2019 – from 01.01.2020
 no further listing possible)
 • Phosphonic acid ester / Polyphosphonates
 • Phthalic acid esters / Phthalates
 • Persistent long-chain polycarboxylic acids
 (short-chain, such as ascorbic acid, tartaric acid, citric
 acid, are permitted)
 • Boron containing acids and their salts
 Bases • (none)
 Other ingrediants • Biphenyl-2-ol
 • Chlorine releasing substances / Active chlorine /
 Electrolyte water
 • Triclosan
 • Perchlorates
 • Ethylenediaminetetraacetic acid (EDTA),
 Diethylenetriaminepentaacedic acid (DTPA),
 Nitrilotriacetic acid (NTA) and their salts as well as
 other comparable chemical-synthetic chelators
 • Formaldehyde und formaldehyde releasing substances
 • Ammonia and ammonia releasing substances
 • Amino-alcohols (monoethanolamine, diethanolamine)
 • Intentionally added components with a particle size of
 < 0.3 µm (nanoparticles)
 • Enzymes (if in the future processes with enzymes will
 be developed, tested and officially recognized for the
 food sector, the list can be reviewed)
 • Bromine compounds

4.2 Criteria concerning ecotoxicity and biodegradability

The assessment of ecotoxicity and biodegradation is based on the EU Ecolabel system
(http://www.eu-ecolabel.de). The so-called critical dilution volume (CDV) is calculated
using the DID list (Detergents Ingredients Database). The calculation of the CDV as a listing
criteria is done for all categories except animal care products (including udder hygiene and
udder care products).

 Evaluation criteria of cleaning, disinfection and hygiene products in the
 Input List for Organic Agriculture and the Input List for Organic Processing
 Page4
 FiBL Projekte GmbH Review March 2019

4.2.1 Calculation of the critical dilution volume (CDV)

The method for calculating the chronic Critical Dilution Volume (CDV) is explained in the
EU-Ecolabel 1. The following information is required to calculate the CDV:

 • Full formulation of the product (all components including)
 • Dosage of the product (normal and maximum dosage)
 • Degradability and toxicity value (from DID list). If substance is missing on the DID
 list A, the corresponding values are calculated according to DID list B. In all cases the
 “worst case”-scenario is used.
The formula for calculating the CDV is as follows:
 ( ) × ( )
 = Ʃ ( ) = Ʃ � � × 
 ( )

CDV = Critical dilution volume of the product
Weight = Quantity of the individual substance in 100g of the product
DF (i) = Degradation factor (from DID list).
TF = Toxicity factor (from DID list)
Dosage = Dosage of the product in % (manufacturer`s declaration)
(i) = Determined ingredient of the product

4.2.2 Maximum limits for the CDV value

The maximum limits for the CDV are set as follows:

 Dosage CDV max.
 Normal dosage: regular use (often daily) 10.000
 Maximum dosage: occasional use (e.g. 1x a week) 20.000

4.2.3 Calculation example for the critical dilution volume (CDV)

Formulation example: Full formulation including quantities

 Components DID-No. Quatity per 100g
 Citric acid 2506 15 g
 Fatty alcohol ethoxylate (C12-18), >2,5 - ≤5 EO 2122 2g
 Ethanol 2529 20 g
 Water - 63 g

Dosage: Normal dosage: 2-3 %. In the sense of a worst case scenario, 3 % is calculated.
Maximum dosage: 10 %.

1 COMMISSION DECISION (EU) 2017/1217 of 23 June 2017 establishing the EU Ecolabel criteria for

hard surface cleaning products
 Evaluation criteria of cleaning, disinfection and hygiene products in the
 Input List for Organic Agriculture and the Input List for Organic Processing
 Page5
 FiBL Projekte GmbH Review March 2019

Calculation of the KDV for all components

 Components Quantity per Degradability Toxicity (TF) CDV per
 100g (DF) component*
 Citric acid 15 0.05 0.825 0.909
 Fatty alcohol 2 0.05 0.001 100.000
 ethoxylate (C12-18)
 Ethanol 20 0.05 0.1 10.000
 Water 63 - - -
 Sum of the CDV of all components 110.909

* CDV per component = Quantity x DF / TF

Calculation of the CDV for the applications of the product

 Application CDV of all components Dosage CDV*
 Normal application 110.909 3 %: 0.03 3.327
 Max. application 110.909 10 %: 0.10 11.090

* CDV = Sum of the CDV of all components x 1000 x Dosage

Evaluation of the test formulation

The calculated CDV of 3.327 meets the requirements for normal dosages (