EUROPEAN COMMISSION

HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

Food and feed safety, innovation

Pesticides and Biocides

Brussels, 22/02/2022
SANTE/ 10704/2021

Information note on Article 20 of Regulation (EC) No 396/2005

as regards processing factors, processed and composite
food and feed1

Please note that this document focuses mainly on processing factors and processed food and feed in a
first step. More detailed provisions as regards composite food and feed (which are covered in principle)
can be developed at a later stage, if needed.

1
This document has been conceived as an information note of the Commission Services. It does not represent the
official position of the Commission. It does not intend to produce legally binding effects. Only the European Court
of Justice has jurisdiction to give preliminary rulings concerning the validity and interpretation of acts of the
institutions of the EU pursuant to Article 267 of the Treaty.

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Contents
1. Introduction .......................................................................................................................................... 3
2. Objectives of the Information note ...................................................................................................... 3
3. Legal background .................................................................................................................................. 4
4. Definitions ............................................................................................................................................. 4
5. General principles for implementation by Member States in their enforcement activities ................ 7
5.1. Calculations ................................................................................................................................... 7
5.2 Different types of processing factors ............................................................................................ 8
5.3 Use of available data sources for processing factors.................................................................. 10
5.4 Relevant general issues for consideration when assessing compliance with MRLs for
processed/composite food and feed ...................................................................................................... 12
5.5 Application of processing factors to MRLs.................................................................................. 13
6. Use of the processing factors in enforcement practice ...................................................................... 15
6.1. The steps for the assessment of analytical results ..................................................................... 15
6.2. Minimum requirements for data received from a FBO .............................................................. 17
6.3. Decision by the competent authority ......................................................................................... 18
7. Calculation Examples .......................................................................................................................... 19
7.1 The calculation of derived MRLs by using processing factors .................................................... 19
7.2 Composite food and feed ........................................................................................................... 21
Literature .................................................................................................................................................... 22
Appendix I ................................................................................................................................................... 24

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1. Introduction
The European Commission (the Commission) carried out an evaluation2 of the plant protection products
(PPP)3 and maximum residue levels (MRL) Regulations4 covering the period of their respective entry into
application until the end of 2018 as part of its regulatory fitness and performance programme (REFIT).
The Commission assessed whether the Regulations are fit for purpose, achieve their objectives while
keeping the European Union (EU) law simple, and removing unnecessary burdens. One of the findings of
the evaluation was that general provisions for processed products are already in place, but those
provisions would benefit from clarification. It is therefore necessary to give guidance to all involved
parties, in particular the competent authorities in the Member States responsible for enforcement, but
also food and feed business operators (FBO), on how to deal with processed products.

This document is an evolving document and will be updated to take account of the experience of the
competent authorities or any new information that may become available. In a first step, this document
mainly focuses on processing factors (Pf) and processed food and feed. More detailed guidance as regards
composite food and feed can be developed at a later stage, if needed.

This information note has been presented to and noted by the representatives of the Member States
during the meeting of the Standing Committee on Plants, Animals, Food and Feed (SCPAFF), section
Phytopharmaceuticals – Pesticides Residues of 22/23 February 2022.

2. Objectives of the Information note

The aim of this document is not to establish EU harmonised processing factors or to work towards setting
of specific maximum residue levels (MRLs) for processed food and feed. The intention is to provide
guidance to Member States (including Official Control Laboratories) on how to implement Article 20
provisions of Regulation (EC) 396/2005 in a harmonised way, ultimately leading to a situation by which
processing factors established by one Member State could be mutually accepted by other Member States.
This document also provides indications for FBOs, including importers from third countries, to prepare
themselves and have the necessary information at hand if national authorities request further
documentation during their official controls. However, it remains ultimately the Member States’
responsibility to decide, after analysis of available information, on whether to use or not to use processing

2
COM(2020) 208 final.
3
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the
placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ
L 309, 24.11.2009, p. 1).
4
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum
residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive
91/414/EEC (OJ L 70, 16.3.2005, p. 1).

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factors and, if used, to decide on an appropriate factor as a basis for taking enforcement action. Some
criteria should be laid down for Member States in this note to assist them to take such a decision.

The intention of this information note is not to lay down details on how a company (e.g., a FBO) should
organise its own checks. It remains entirely the responsibility and duty of the FBOs to act in due diligence.

3. Legal background
Article 20(1) of Regulation (EC) No 396/2005 states that where MRLs are not set out in Annexes II or III for
processed and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for
the relevant product covered by Annex I, taking into account changes in the levels of pesticide residues
caused by processing and/or mixing. Changes caused by processing and/or mixing can be taken into
account, for example, by using a processing factor or by an expert assessment of the processing process
based on a scientifically robust data. In addition, Article 20 of this Regulation empowers the Commission
to establish Annex VI for specific concentration or dilution factors for certain processing and/or mixing
operations or for certain processed and/or composite products. The Commission has not used this
empowerment and Annex VI has not yet been established. Annex I on products of plant and animal origin
to which MRLs apply contains a category 1200000 for “Products or parts of products exclusively used for
animal feed production”: this category is empty, as specific MRLs have not yet been set for such products.
Annex I contains also a category for processed food products (category 1300000) which is relevant e.g.
for processed products in which residues could stem from biocidal uses. This category is still empty as
well, therefore, specific MRLs for processed products have not yet been set at European Union (EU) level.

Where specific MRLs are not set out in Annexes II or III of Regulation (EC) No 396/2005 for processed
and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for the
relevant product covered by Annex I, taking into account changes in the levels of pesticide residues caused
by processing and/or mixing. The provisions of Article 20 of Regulation (EC) No 396/2005 therefore apply
to products for which MRLs have been established in Annex II and III (Article 18(1)(a)), but also to MRLs
established at the default level of 0.01 mg/kg or at a specific limit of quantification (LOQ) (Article 18(1)(b)).
Those specific LOQs can be established for a given substance-commodity combination in any of the
Annexes II, III or V of Regulation (EC) No 396/2005. For MRLs established at a specific LOQ or the default
value of 0.01 mg/kg, specific provisions apply, as set out in Chapter 5.5.

The Regulation does not give any more detail on how compliance of processed or composite food or feed
should be established and implementation of these provisions in enforcement practice is the
responsibility of the Member States’ national authorities in charge of official controls. This document lays
down a standard approach. Specific cases may needed to be dealt with separately.

4. Definitions
For the purpose of this information note, the following definitions apply:

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Products covered by Annex I of Regulation (EC) No 396/2005: This information note covers all products
covered by Annex I of Regulation (EC) No 396/2005 as those are the products in which MRLs compliance
must be evaluated. The listed products in Annex I of this Regulation are mostly unprocessed products, but
Annex I also includes some processed (dried) products, such as tea, certain spices or herbal infusions.
MRLs apply directly to them and no further drying factor should be applied to them. If other processing
operations would be applied to those products, processing factors would still need to be considered.

Unprocessed products: Unprocessed products in the context of this document are those listed in Annex I
of Regulation (EC) No 396/2005. For the purpose of Regulation (EC) No 396/2005 the most important
unprocessed products are the raw agricultural products, including those products that have been chilled,
frozen5, deep-frozen or thawed.

Processing: Processing is defined in Article 2(1)(m) of Regulation 852/20046 as “Any action that
substantially alters the initial product, including heating, smoking, crushing, curing, maturing, drying,
marinating, extraction, extrusion or a combination of those processes”.

In addition, operations that remove a part of the product such as peeling, pitting, cleaning, husking,
trimming or milling are considered in general processing operations for the purpose of this document,
expect a few operations7 that are defined in column 6 of Annex I of Regulation (EC) No 396/2005 and are
related to specific products.

Washing processes would generally not be considered processing operations. However, if washing with
for example chlorinated water changes chlorate levels in foodstuffs this step would need to be considered
but cannot be covered by processing factors. For chlorate residue in processed food, a footnote A8 has
been introduced into Regulation (EC) No 396/2005.

Processed products: Processed products are products resulting from the processing of unprocessed
products. These products may contain ingredients that are necessary for their manufacture or to give
them specific characteristics.

5
Freezing or deep freezing may include a blanching step if such process does not substantially alter the initial product.
6
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of
foodstuffs (OJ L 139, 30.4.2004, p. 1).
7
Activities such as cleaning, husking or trimming prior to freezing fruit or vegetables, are not considered to be
processing operations for the purpose of this document.
8
To take into account the specific situation of chlorate residues, in processed food (including for the purpose of this
Regulation foodstuffs that have been derived using processes listed in Article 2(1)(n) of Regulation (EC) No
852/2004), that has come in contact with products containing chlorate residues, or that contains ingredients with
such residues, such as processing aids or drinking water, used in compliance with the respective legal requirements,
these additional contributions of chlorate residues should be taken into account when determining the permitted
content of chlorate residues in or on the processed food products in accordance with Article 20 (1) of this Regulation.
The burden of proof regarding the level of those additional contributions lies with the food and feed business
operator.

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Examples of processed products: juice, wine, oil, compote, puree, cooked vegetable, peeled fruits, cereal
flour, canned pulses, pulp, meal, bran, plant extracts.

Processing factor (Pf): Calculated as the ratio of the residue concentration in the processed product and
the residue concentration in the relevant unprocessed product covered by Annex I using the residue
definition for enforcement given in Regulation (EC) No 396/2005.

Fully acceptable processing factor: Processing factor which is based on a study that complies with the
criteria that the trial is based on the Good Laboratory Practice (GLP) or has been conducted before 1993
(GLP not mandatory), the analytical method is fit for purpose9, the storage period is covered by storage
stability data10, the process is considered as representative and the residue in the relevant unprocessed
product covered by Annex I is ≥ LOQ.

Indicative processing factor: Processing factor which is based on a study that complies with the same
criteria as for a fully acceptable processing factor except that information on storage stability was not
available.

Median processing factor: The median value of a dataset of indicative or fully acceptable processing
factors for a given process. An acceptable median Pf should be based on three or more fully acceptable
individual Pf values for one combination of active substance, process and commodity or on two or more
fully acceptable individual Pf values for one combination of active substance, process and commodity with
a variation of less than 50%.

Composite food or feed (corresponding to compound feed in feed legislation): Composite food or feed
in the context of Art. 20 of Regulation (EC) No 396/2005 means food or feed containing more than one
ingredient and at least one ingredient derived from an agricultural product (plant and/or animal origin)
processed and/or unprocessed in different amounts. This definition differs from that given in Article 2(14)
of Regulation 2019/625 supplementing Regulation (EU) 2017/62511.

9
Guidance Documents on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and
Monitoring Purposes, as applied in its latest version.
10
Database of processing techniques and processing factors compatible with the EFSA food classification and
description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food.
11
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and
other official activities performed to ensure the application of food and feed law, rules on animal health and welfare,
plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No
1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the
European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council
Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No
854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC,
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (OJ L 95,
7.4.2017, p. 1)

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5. General principles for implementation by Member States in their

enforcement activities
5.1. Calculations

Calculation of a processing factor (see also Chapter 7.1):

The processing factor is calculated from the residue level in the processed product divided by the residue
level in the corresponding raw commodity (unprocessed product):

𝑅𝑒𝑠𝑖𝑑𝑢𝑒 𝑖𝑛 𝑡ℎ𝑒 𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑓𝑟𝑎𝑐𝑡𝑖𝑜𝑛 (𝑚𝑔/𝑘𝑔)

𝑃𝑓 =
𝑅𝑒𝑠𝑖𝑑𝑢𝑒 𝑖𝑛 𝑡ℎ𝑒 𝑟𝑎𝑤 𝑐𝑜𝑚𝑚𝑜𝑑𝑖𝑡𝑦 (𝑚𝑔/𝑘𝑔)

Pf is > 1: Residues concentrated in the processed product.

Pf is < 1: Residues declined in the processed product (due to dilution, removal or degradation).
Pf = 1: Processing did not result in a change of residue concentrations.

Calculation of a “derived MRL” applicable to a processed product using a processing factor (see also
Chapter 7.1):

In order to assess compliance with an MRL, the “derived MRL” for the processed product is obtained by
multiplying the Pf with the MRL of the relevant unprocessed product covered by Annex I:

𝑫𝒆𝒓𝒊𝒗𝒆𝒅 𝑴𝑹𝑳 𝑓𝑜𝑟 𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 (𝑚𝑔/𝑘𝑔)

= 𝑃𝑓 ∗ 𝑀𝑅𝐿 𝑜𝑓 𝑡ℎ𝑒 𝑟𝑒𝑙𝑒𝑣𝑎𝑛𝑡 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼 (𝑚𝑔/𝑘𝑔)

The term “derived MRL” denotes a convenience of a calculation; the processing factors are for converting
the MRLs applicable in foods covered by Annex I to a MRL applied to the respective processed product.

Calculation of an MRL applicable to a composite food or feed made of different ingredients

𝑫𝒆𝒓𝒊𝒗𝒆𝒅 𝑴𝑹𝑳 𝑓𝑜𝑟 𝑐𝑜𝑚𝑝𝑜𝑠𝑖𝑡𝑒 𝑓𝑜𝑜𝑑 𝑜𝑟 𝑓𝑒𝑒𝑑 𝑐𝑜𝑛𝑠𝑖𝑠𝑡𝑖𝑛𝑔 𝑜𝑓 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐴 𝑎𝑛𝑑 𝐵 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦
𝐴𝑛𝑛𝑒𝑥 𝐼 (𝑚𝑔/𝑘𝑔)
= (𝑀𝑅𝐿 𝑜𝑓 𝑡ℎ𝑒 𝑟𝑒𝑙𝑒𝑣𝑎𝑛𝑡 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐴 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼 (𝑚𝑔/𝑘𝑔)
∗ 𝑝𝑒𝑟𝑐𝑒𝑛𝑡𝑎𝑔𝑒 𝑜𝑓 𝑡ℎ𝑒 𝑟𝑒𝑙𝑒𝑣𝑎𝑛𝑡 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐴 𝑖𝑛 𝑡ℎ𝑒 𝑐𝑜𝑚𝑝𝑜𝑠𝑖𝑡𝑒 𝑓𝑜𝑜𝑑 𝑜𝑟 𝑓𝑒𝑒𝑑)
+ (𝑀𝑅𝐿 𝑜𝑓 𝑡ℎ𝑒 𝑟𝑒𝑙𝑒𝑣𝑎𝑛𝑡 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐵 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼 (𝑚𝑔/𝑘𝑔)
∗ 𝑝𝑒𝑟𝑐𝑒𝑛𝑡𝑎𝑔𝑒 𝑜𝑓 𝑡ℎ𝑒 𝑟𝑒𝑙𝑒𝑣𝑎𝑛𝑡 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐵 𝑖𝑛 𝑡ℎ𝑒 𝑐𝑜𝑚𝑝𝑜𝑠𝑖𝑡𝑒 𝑓𝑜𝑜𝑑 𝑜𝑟 𝑓𝑒𝑒𝑑)

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If in the composite food or feed the unprocessed products covered by Annex I are used in a processed
form (e.g., dried), then processing factors should be considered in addition. It should be noted that this
does not apply to those products covered by Annex I which are already dried e.g., tea, herbal infusions
and spices.

A derived MRL for composite feed may be calculated only if MRLs or derived MRLs are available for all
feed materials from plant or animal origin.

5.2 Different types of processing factors

Processing factors can be divided into substance-specific processing factors and generic processing factors
for certain standard processing operations (e.g., drying by removing of water). Generic processing factors
should only be used when substance specific factors are not available.

Substance specific processing factors

A substance-specific processing factor is specific to a certain active substance in a certain commodity that
has undergone a certain process (e.g., Pf of 0.32 for ametoctradin in pasteurised grape juice). For some
active substances and processes, processing factors may vary considerably even when obtained under
comparable conditions. The use of a median factor is therefore preferred over the use of an individual
factor. As the median processing factor in the European Food Safety Authority’s (EFSA)(EU) database can
be indicated as “reliable”, “not reliable” or “indicative”, the reliable median processing factor should be
used.

Extrapolation of substance specific processing factors

In certain cases and provided that processes are comparable, extrapolation between similar commodities
could be considered12,13. Those cases could include the extrapolation of processing factors for processed
products derived from raw material classified in the same commodity (sub)group e.g., cherries to plums
treated with the same active substance. Also, in some cases it could be possible to apply the processing
factor from an active substance to a different active substance for the same commodity based on physical
properties such as e.g., fat solubility. Extrapolations of this kind are left to the expert judgement of the
Member States and no general rules can be provided.

Generic processing factors

Generic processing factors are specific to a certain process (e.g., dehydration or dilution with water).

The drying factor only takes into account concentration of the pesticide residue due to evaporation of
water from the unprocessed product covered by Annex I of Regulation (EC) No 396/2005 during drying.

12
OECD Guidelines for the Testing of Chemicals, Section 5, Test No. 508: Magnitude of the Pesticide Residues in
Processed Commodities.
13
Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and
extrapolation of residue data of residue data on products from plant and animal origin.

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Drying factors are less suitable because the pesticide residue concentration in the dried commodity may
actually be lower than anticipated due to degradation.

Commodity-specific drying factors are calculated based on the dry matter content in the starting material
(unprocessed product covered by Annex I) and the dried commodity derived thereof, and are thus specific
for the drying process used by a certain producer of dried commodities. Dry matter contents for the
starting material and the dried commodity thereof can be obtained from the producer of the dried
commodity14.

𝑑𝑟𝑦 𝑚𝑎𝑡𝑡𝑒𝑟 𝑖𝑛 𝑑𝑟𝑖𝑒𝑑 𝑐𝑜𝑚𝑚𝑜𝑑𝑖𝑡𝑦, %

𝐷𝑟𝑦𝑖𝑛𝑔 𝑓𝑎𝑐𝑡𝑜𝑟 =
𝑑𝑟𝑦 𝑚𝑎𝑡𝑡𝑒𝑟 𝑖𝑛 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼, %

The MRL of the dried commodity can be calculated by multiplication of the MRL of the unprocessed
product covered by Annex I by the drying factor for the corresponding dried commodity.

𝐷𝑒𝑟𝑖𝑣𝑒𝑑 𝑀𝑅𝐿 (𝑚𝑔/𝑘𝑔) = 𝑀𝑅𝐿 𝑖𝑛 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼 (𝑚𝑔/𝑘𝑔) ∗ 𝑑𝑟𝑦𝑖𝑛𝑔 𝑓𝑎𝑐𝑡𝑜𝑟

Default drying factors9 are based on the dry matter content in the starting material (unprocessed product
covered by Annex I) and the dried commodity derived thereof for the most common dried products.

The yield factor (in percentage) is the mass of the processed commodity (in kg) divided by the mass of the
corresponding relevant unprocessed product covered by Annex I of Regulation (EC) No 396/2005 (in kg)
and multiplied by 100 to get a percentage. In many cases, e.g., when the commodity is heated, the residue
can be hydrolysed, or when the commodity is boiled, the residues can be transferred to the water, or
when a fraction of the product is removed by the process, most of the residues can be removed with it,
the residue level in the unprocessed product covered by Annex I could be highly overestimated if
calculated with a yield factor. Therefore, the yield factor could – together with information on the physico-
chemical properties of the active substance - give an indication on whether the derived MRL of the
processed product is likely to be compliant with the MRL of the unprocessed product covered by Annex I
and therefore could be considered only when there are no other processing factors available.

14
RIVM, Bilthoven, Netherlands, 11 june 2020, Processing factors for dried commodities.

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𝑚𝑎𝑠𝑠 𝑜𝑓 𝑡ℎ𝑒 𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑐𝑜𝑚𝑚𝑜𝑑𝑖𝑡𝑦( 𝑘𝑔)

𝑌𝑖𝑒𝑙𝑑 𝑓𝑎𝑐𝑡𝑜𝑟 (%) = ∗ 100
𝑚𝑎𝑠𝑠 𝑜𝑓 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼( 𝑘𝑔)

Example: the yield factor between olive oil (processed commodity) and olives (unprocessed product) is
considered to be 20%. If no other processing factors are available, this factor could be considered, but
only if information on the physico-chemical properties of the residues, in particular their fat/water
solubility (via log Kow, also known as logP), is also taken into account.

Assuming that residues fully concentrate into the processed commodity of olive oil, the processing factor
is derived according to the following equation:

1 𝑚𝑎𝑠𝑠 𝑜𝑙𝑖𝑣𝑒𝑠 100

𝑃𝑓 = = = =5
𝑦𝑖𝑒𝑙𝑑 𝑓𝑎𝑐𝑡𝑜𝑟 𝑚𝑎𝑠𝑠 𝑜𝑙𝑖𝑣𝑒 𝑜𝑖𝑙 20

The derived MRL of the olive oil (processed commodity) can be calculated by multiplication of the MRL of
olives (unprocessed product) by the processing factor of 5.

5.3 Use of available data sources for processing factors

A description of the most used processes can be retrieved from the EFSA compendium. Processing factors
can be retrieved from the EFSA (EU) database, national databases or further sources and can be used by
the Member States’ enforcement authorities. However, processing factors are product and substance
specific and processing methods may vary between different producers and/or recipes and often cannot
be standardised. The compilation of processing factors can therefore only serve as indication, but it
remains the responsibility of FBOs to provide more detailed information on their particular processes (i.e.,
description of the process including yield factors, temperature, pH, duration, concentration factors,
dilution factors, addition of ingredients, fractionation), their effect on the residue concentration, and to
ensure, if possible, that retention samples of relevant unprocessed products covered by Annex I of
Regulation (EC) No 396/2005 are available. It is advisable to prepare such information proactively so it can
be made available to the competent authorities in the Member States on their request without delay.

EFSA publications and EFSA (EU) database

Processing factors for certain substance-product-process combinations are available in the published
EFSA conclusions on the peer review or in the EFSA reasoned opinions for the respective active substance.

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The EFSA (EU) database includes processing factors from EFSA publications until June 2016. Work is
currently ongoing to implement additional processing information from more recent EFSA publications. It
has to be noted that the processing factors in the database could be different from those in EFSA’s
publications as the EFSA (EU) database may contain more recent information (part of the process of
adding processing factors to the EFSA (EU) database is the re-assessment of all processing studies).
Therefore the processing factor from the EFSA (EU) database should be preferred when available.
Processing factors included in the EFSA (EU) database have been derived from processing studies
complying with a minimum of quality criteria (i.e. representativeness of the processing procedures,
residue definitions, minimum number of trials, validity of the analytical method, compliance with
standards of GLP, sample storage conditions).

The EFSA (EU) database of processing factors for pesticides in food provides substance-specific median
processing factors. This database is based on the residue definition for enforcement and substance-
specific processing factors derived from this database are suitable to get an indication of the compliance
of a sample with the established MRL, if the processing of the food or feed under investigation complies
with the process described in the EFSA compendium.

National databases in the European Union and the Joint Meeting on Pesticide Residues (JMPR) reports

If no such processing factors are established for the respective active substance-product-process
combination, processing factors from Member States’ national databases could be used, for instance the
following (not exhaustive list): The German Federal Institute for Risk Assessment (BfR), the Dutch National
Institute for Public Health and the Environment (RIVM), the Spanish Agency for Food Safety and Nutrition
(AESAN). There is no hierarchy among Member States’ national databases, in case of multiple processing
factors are available, the processing factor that is most appropriate for the specific situation should be
taken. It should be noted that the RIVM database refers to the residue definitions for risk assessment
while the other databases refer to the residue definition for enforcement. Sometimes, the definitions for
risk assessment and enforcement can differ.

In addition, the processing factors listed in the Joint Meeting on Pesticide Residues (JMPR) reports could
be used, provided that the residue definitions for enforcement derived by JMPR match with the EU residue
definitions for enforcement.

Other sources

If no processing factors are available in the EFSA database, EFSA publications, national databases or JMPR
reports and there are no possibilities for extrapolation of substance specific processing factors, the
alternative sources e.g., generic processing factors, data from the literature, etc. could be used. Some
other sources are listed in the Chapter on Literature. The processing factor which has been selected for
the assessment, might be replaced by a process-specific value provided by the concerned FBO, if
considered appropriate. For drying factors, different food sectors have established lists with drying factors

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at the national or European level. However, the drying factors in those lists may differ due to the different
methods used for calculating them. The preference should be given to the national databases and only if
the necessary information is not available, databases provided by industry or data from literature could
be used if the competent authority deems this appropriate.

Drying factors can also be implicitly obtained from the “Raw Primary Commodity (RPC) model”15 or the
“Compendium of Representative Processing Techniques investigated in regulatory studies for
pesticides”16. Other sources could be databases from public institutions e.g., universities or stakeholder
associations.

5.4 Relevant general issues for consideration when assessing compliance with MRLs
for processed/composite food and feed
When assessing MRL compliance of pesticides residues in food and feed which have been processed or
composed of more than one ingredient, the following issues should be in general considered, regardless
of whether or not a processing factor is available:

 Recalculation of the MRLs applicable to processed products according to Article 20 of Regulation (EC)
396/2005;
a) changes of the concentration of the residue caused by water loss by drying or dilution (with water)
processes;
b) changes of the concentration of the residue caused by processing and by removing part of the
products (e.g., peeling, pitting, extracting oil or in milling fractions like bran);
c) relative proportions of the ingredients in composite food and feed (i.e., food or feed containing
more than one ingredient);
d) actual residue definition for enforcement of the active substance;
e) changes of the residue concentration caused by the physico-chemical action of the process on the
residue (e.g., degradation, chemical reaction, vaporisation).

 Assessment of the compliance of the analytical result with the MRL.

The measurement uncertainty (MU), i.e., specific MU or default MU of 50%17, is taken into account when
competent authorities take a decision on compliance with MRLs. As regards the use of a measurement

15
The raw primary commodity (RPC) model: strengthening EFSA’s capacity to assess dietary exposure at different
levels of the food chain, from raw primary commodities to foods as consumed. EFSA Supporting publication 2019:EN-
1532.
16
Database of processing techniques and processing factors compatible with the EFSA food classification and
description system FoodEx 2Objective 1: Compendium of Representative Processing Techniques investigated in
regulatory studies for pesticides. EFSA Supporting publication2018:EN-1508.
17
Document Nº SANTE/12682/2019 on analytical quality control and method validation procedures for pesticides
residues analysis in food and feed, as applied in its latest version.

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uncertainty with a lower confidence level as a precautionary measure the Working Instructions for the
Rapid Alert System for Food and Feed (RASFF WI)18 applies.
However, it is stressed that Article 19 of Regulation (EC) No 396/2005 prohibits the processing, and/or
mixing for dilution purposes with the same or other products, of the products covered by Annex I not
complying with Articles 18(1) or 20 with a view to placing them on the market as food or feed or feeding
them to animals. This principle can never be overruled by the use of a processing factor (e.g., mixing
different lots of the same plant material with different levels of residues of an active substance (some
compliant with the MRL, others not), in order to get a product that complies with the MRL set in Annex I.

In addition, no processing factor should be used or taken into account if the active substance has been
added during or after processing (e.g., a fungicide use after drying or an insecticide use in a flour storage
facility).

Due to the physico-chemical properties of the active substance and the processing technique used for the
production of a processed product, the concentration of the residue of the active substance may decrease
or increase in the processed product compared to the initial concentration in the relevant unprocessed
product covered by Annex I of Regulation (EC) No 396/2005.

5.5 Application of processing factors to MRLs

Processing factors should be considered and a compliance assessment of the residue should be performed
only when data of the raw material is not available or when FBOs cannot demonstrate conformity
according to Regulation (EC) 396/2005.

Processing factors are applicable to approved and non-approved active substances in the EU and refer to
the residue definition for enforcement laid down in Regulation (EC) No 396/2005. They are applied also
to MRLs established at a specific LOQ or at the default level of 0.01 mg/kg. In the cases where the
calculated MRL of the processed product is lower than the specific LOQ or the default level of 0.01mg/kg,
the existing MRL at the specific LOQ value or the default level should be kept as lower levels would not be
analytically achievable.

In case several processing factors are available, it is recommended to use median Pfs from the EFSA (EU)
or national databases. In case only single values from the EFSA (EU) or national databases (including
indicative processing factors) are available, these could be used. If there are different choices because of
different processes used and no information on the process under investigation is available, the most
appropriate processing factor for this particular process should be used.

If application of the available and most suitable processing factors (according to the hierarchy set out
above) indicates that the product might not be in compliance with the MRL, the competent authority of
the Member State responsible for enforcement may give the respective FBO the opportunity to provide:

18
RASFF WI: Guideline for the calculation of consumer intake and evaluation of the risk for pesticide residues,
as applied in its latest version

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1. evidence that compliant unprocessed products as listed in Annex I to Regulation (EC) No 396/2005
were used as starting material for processing (this must always be proven), or
2. more specific Pfs for their processes, which could be substance specific or generic processing
factors, within a certain deadline. If those were made available within the deadline provided,
these could be used provided that the competent authority of the Member State considers them
appropriate based on their expert judgement. If that is the case, studies deriving the Pf should
also be sent to the Member States’ enforcement authority which can later share these with EFSA.

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6. Use of the processing factors in enforcement practice

A tiered approach is proposed to be followed by Member States’ competent authorities if an analytical
result of an official control sample (processed or composite) is obtained and a decision about its
compliance with MRLs needs to be made. It also contains an additional risk assessment step, if this is
needed in view of the result.

6.1. The steps for the assessment of analytical results

The steps taken for assessing the MRL compliance are explained below and presented in Appendix I.

Step 1 (Initial estimation of compliance)

Starting point: analysis of the processed product. Comparison of the analytical result 17,20 to the MRL of
the relevant unprocessed product covered by Annex I of Regulation (EC) No 396/2005.

1. Dilution or no change is expected

Residues are expected to be the same or lower in a processed product19.
Case a) the measured value in the processed products does not exceed the MRL for the relevant
unprocessed product covered by Annex I 20. However, if dilution is expected, the MRL in the unprocessed
product covered by Annex I may still be exceeded. In certain cases it is up to the Member State to decide
if they want to take further action, e.g., in the case of washing/rinsing of apples and pears, as these are
standard procedures therefore Member State may not wish to continue.
To take further action:
 Yes  Move to step 2
 No  No action
Case b) the measured value in the processed product exceeds the MRL for the relevant unprocessed
product covered by Annex I 20  Move to step 2

2. Concentration is expected
Residues are expected to be higher in a processed product.
Case a) the measured value in the processed product exceeds the MRL for the relevant unprocessed
product covered by Annex I 20  Move to step 2

19
It should be noted that if there is a dilution and the analytical value falls below the laboratory’s reporting limit
then the results might not be reported
20
Discussion on the use of analytical measurement uncertainty are still ongoing. This document will be updated
accordingly.

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Case b) the measured value in the processed product does not exceed the MRL for the relevant
unprocessed product covered by Annex I 20 No further action

Step 2 (Decision on the use of a Pf)

In the cases of Step 1a), 1b) and 2a), non-compliances may be expected in some processed products that
have undergone processes resulting in expected dilution or concentration of residues. In such cases the
use of Pfs should be considered.
Question: Is an appropriate Pf available?
 Yes  Take the Pf into account in the final decision on compliance.
 No  FBO to provide justification on why the processed product complies with the MRL (i.e., data on
processing, other relevant information).
Evidence of compliant raw materials
If the FBO can prove beyond any doubt, e.g., by demonstrating through its incoming goods safety
management system etc., that compliant commodities according to Annex I of Regulation (EC) No
396/2005 have been used, the processed product made thereof has also to be considered compliant,
provided that the same active substance was not added during the processing steps. In this case, it is not
necessary to provide processing factors.

Step 3: (Final decision on compliance)

Assess justification and specific process information provided by the FBO and take a decision on
enforcement taking into account all elements. When taking the decision on compliance or non-
compliance, the MU and the variability of processing factors should be taken into account17,18.
In case where non-compliance is established, the Member State will need to assess whether the sample
constitutes a possible health risk, taking this additional step 4.

Step 4 (If appropriate, decision on health risk)

Does the amount of pesticide in the processed product constitute a consumer health risk?18
For food: Analytical result on processed products to be put in EFSA’s Pesticide Residue Intake Model
(PRIMo) and matched with the consumption data for the relevant product covered by Annex I of
Regulation (EC) 396/2005. EFSA PRIMo contains a few processed products. In such cases, the residue in
the processed product is matched with the consumption data of the processed product. In cases where
there is no consumption information on the processed commodity, the corresponding calculated residue
of the unprocessed product is used in PRIMo e.g., raisins and table grapes. PRIMo might not cover all
possible processed products to be developed in the future e.g., dried banana peels and onion oil.

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Therefore, it is for the FBO to prove that the processed product is safe. It should be noted that the residue
definition for enforcement and for risk assessment may be different and therefore conversion factor may
need to be considered in order to convert residues based on the residue definition for monitoring into the
residue definition for risk assessment.
Alternatively, if there is no consumption data on the processed commodity in PRIMo, other databases or
sources could be used.
For feed: national residue intake models are used, e.g., the FAVV-PSTI21 tool in Belgium.
The risk for animal health is estimated taking into account the percentage of the product in the daily
ration. In the case of food-producing animals, the safety of food derived from these animals must also be
assessed.
Further relevant issues for consideration in risk assessment for processed food or feed

For the risk assessment of processed food or feed the following should be considered:

a) the existence or the lack of specific consumption data for the processed product. In the absence
of such, the consumption figures for the unprocessed product may be used.
b) the principles laid down in the RASFF WI (in its latest revision)18.

6.2. Minimum requirements for data received from a FBO

FBOs are not obliged to provide systematically specific data on processing factors for their products,
neither does this note prescribes how they should organise their own checks. It remains up to the FBO to
apply due diligence. However, if FBOs wish that Member States’ competent authorities consider more
specific information on their processes, they can provide additional information to the competent
authorities upon their request. This information is intended to assist Member States to take the most
accurate decision possible. If such data are submitted, they must however comply with certain minimum
requirements.

The minimum requirements are the following:

 Processed product, e.g., olive oil.

 Relevant unprocessed product covered by Annex I or the product from which processing started,
e.g., olives for oil production.
 Code of the relevant unprocessed product covered by Annex I of Regulation (ΕC) 396/2005: the
seven-digit code as it appears in the first column of Annex I of Regulation 396/2005 e.g., 0402010
(olives for oil production).
 Proposed processing factor per active substance according to the residue definition for
enforcement.

21
https://www.favv-afsca.be

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 Origin of where the proposed processing factor (name of the database, Pf calculated by FBO
based on analyses of raw and processed product) was found.
In addition, the following requirements may be needed to complete the minimum requirements in the
following circumstances:
 In case processing factors from EFSA or national databases cannot be used, the rationale as to
why the processed product complies with the MRL for the corresponding relevant product
covered by Annex I of Regulation (EC) No 396/2005. Depending on the active
substance/commodity combination, such a rationale may include the following elements:
o Description/flowchart of the process (including yield factor, conditions during processing
such as temperatures, pH, addition of ingredients) to show that it complies with the
process mentioned in the EFSA compendium, if applicable, and thus whether the available
processing factors can be used;
o Analytical results of the starting material and the corresponding processed commodity
used to calculate processing factors indicating unambiguously the batch numbers of the
starting material and the corresponding batch numbers of processed products. Two
replicate datasets for each process are required as a minimum. Where results (processing
factor) of the two datasets differ by more than 50 %, further studies shall be provided to
derive a consistent processing factor.
 The FBO should report values as measured without deducting measurement uncertainty for
reporting their results to the competent authority. The MU will be considered by the competent
authority as laid down in Chapter 7.1. Residues should be measured according to the residue
definition for enforcement as listed in the Annexes to Regulation (EC) 396/2005.
 Information about the storage period of the samples.
 Other supporting data, if appropriate.

6.3. Decision by the competent authority

The competent authority assesses the information provided by the FBO. For example:
 In case multiple processing factors are available from a FBO for a certain substance-product-
combination, the median value should be applied. As a precondition to this procedure, the
underlying studies must be evaluated as acceptable.
 Description/flowchart of the process (including yield factor, conditions during processing such as
temperatures, pH, addition of ingredients).
 The analytical method used to determine the Pf and whether it is validated.
 Sufficient information submitted on analytical methods, storage of samples and process details.

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If there is no information available in the EFSA (EU) or national databases and if the FBO does not provide
the necessary processing factor or if the competent authority deems that factor inappropriate in view of
the justification given, the competent authority can itself estimate a substance specific processing factor,
based on the available information and with the objective of maximum protection of human health. This
includes a processing factor of one, meaning that the MRL of the relevant product covered by Annex I of
Regulation (EC) No 396/2005 is applicable.

7. Calculation Examples
7.1 The calculation of derived MRLs by using processing factors
The following chapter provides some calculation examples for the use of substance specific and generic
processing factors in Member States’ enforcement activities. For the purpose of the examples, as these
illustrate the final decision on a compliance or non-compliance in the context of official controls, a default

MU of 50% has been used. MU is considered in favour of the FBO.

𝑫𝒆𝒓𝒊𝒗𝒆𝒅 𝑴𝑹𝑳 𝑓𝑜𝑟 𝑡ℎ𝑒 𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 (𝑚𝑔/𝑘𝑔)

= 𝑃𝑓 ∗ 𝑀𝑅𝐿 𝑜𝑓 𝑡ℎ𝑒 𝑟𝑒𝑙𝑒𝑣𝑎𝑛𝑡 𝑢𝑛𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑒𝑑 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑐𝑜𝑣𝑒𝑟𝑒𝑑 𝑏𝑦 𝐴𝑛𝑛𝑒𝑥 𝐼 (𝑚𝑔/𝑘𝑔)

Pf is > 1: Residues concentrated in the processed product.

Pf is < 1: Residues declined in the processed product.
Pf = 1: Processing did not result in a change of residue concentrations.
MRLs marked with an asterisk (*) indicate the MRLs which have been established at the LOQ or the default
value of 0.01 mg/kg.
Residue content MRL Pf “Derived MRL” for a Status of the sample
in processed processed product according to Regulation
product (EC) No 396/2005

2.2 ± 1.1 mg/kg 1.5 mg/kg in (Median 1.5*1.4=2.1 mg/kg A level of 2.2 ± 1.1 mg/kg
of penthiopyrad fresh plums Pf) 1.4 for penthiopyrad in dried
in unpitted dry with stones dried plums is compliant.
prunes plums22
(prunes)

2.0 ± 1.0 mg/kg 5 mg/kg in (Median 5*0.5= 2.5 mg/kg A level of 2.0 ± 1.0 mg/kg
of imidacloprid beans (with Pf) 0.5 for imidacloprid in canned
in pods)

22
EFSA (EU) Database

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Residue content MRL Pf “Derived MRL” for a Status of the sample

in processed processed product according to Regulation
product (EC) No 396/2005

beans (with beans beans (with pods), is

pods), canned (with compliant.
pods),
canned 23
2.5 ± 1.25 mg/kg 0.01* mg/kg 0.50 for 0.01*0.5 = 0.005mg/kg, A level of 2.5 mg/kg ±
of chlorothalonil in table dried as the derived MRL is 1.25 chlorothalonil in
21
in raisins grapes grapes below 0.01 mg/kg, the raisins is not compliant
MRL of 0.01 mg/kg will be unless the FBO can
considered as a derived demonstrate the
MRL. compliance of the
unprocessed product
covered by Annex I.

0.03 ± 0.015 0.01*mg/kg 2.8 for 0.01*2.8 = 0.028 mg/kg A level of 0.03 mg/kg±
mg/kg of in fresh dried 0.015 carbofuran in dried
carbofuran in grapefruits pulp22 pulp of grapefruits is
dried pulp of compliant.
grapefruits
(citrus pulp,
dried (feed))
0.026 ± 0.013 0.01* mg/kg 0.5 for 0.01*0.5= 0.005mg/kg, A level of 0.026 ± 0.013
mg/kg of in rice polished as the derived MRL is mg/kg of profenofos in
24
profenofos in rice below 0.01 mg/kg the polished rice (basmati) is
rice (basmati, MRL of 0.01 mg/kg will be not compliant unless the
polished) considered as a derived FBO can demonstrate the
MRL compliance of the
unprocessed product
covered by Annex I.
0.50 ± 0.25 0.10 mg/kg (Median 0.10*1.4 = 0.14 mg/kg A level of 0.50 ± 0.25
mg/kg of in wheat Pf) 1.421 mg/kg benzovindiflupyr
benzovindiflupyr in wheat bran is not
in wheat bran compliant unless the FBO
can demonstrate the

23
EFSA Reasoned Opinion on the Review of the existing maximum residue levels for imidacloprid according to Article
12 of Regulation (EC) No 396/2005
24
Commission Implementing Regulation (EU) 2017/660 of 6 April 2017 concerning a coordinated multiannual control
programme of the Union for 2018, 2019 and 2020 to ensure compliance with maximum residue levels of pesticides
and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin

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Residue content MRL Pf “Derived MRL” for a Status of the sample

in processed processed product according to Regulation
product (EC) No 396/2005

compliance of the
unprocessed product
covered by Annex I.
0.36 ± 0.18 2.00 mg/kg (Median 2.0*0.08 = 0.16 mg/kg A level of 0.36 ± 0.18
mg/kg of in fresh Pf) 0.0821 mg/kg boscalid in apple
boscalid in apple apples juice (clarified,
juice (clarified, pasteurised) is not
pasteurised) compliant unless the FBO
can demonstrate the
compliance of the
unprocessed product
covered by Annex I.
0.74 ± 0.37 0.50 mg/kg (Median 0.5*0.81 = 0.41 mg/kg A level of 0.74 ± 0.37
mg/kg of in olives for Pf) 0.81 mg/kg of lambda-
lambda- oil pressed, cyhalothrin in olive oil is
cyhalothrin in production refined compliant.
olive oil oil21

7.2 Composite food and feed

If, at a later stage, more detailed guidance as regards composite food and feed is needed, calculation
examples will be presented in this chapter. For the way to calculate MRLs for composite products, please
see Chapter 5.

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Literature
1. European database of processing factors for pesticides in food
https://zenodo.org/record/1488653
2. Database of processing techniques and processing factors compatible with the EFSA food
classification and description system FoodEx 2 Objective 1: Compendium of Representative
Processing Techniques investigated in regulatory studies for pesticides
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2018.EN-1508
3. Database of processing techniques and processing factors compatible with the EFSA food
classification and description system FoodEx2 related to pesticide residues Objective 2: Linking
the processing techniques investigated in regulatory studies with the EFSA food classification
and description system FoodEx2
https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2018.EN-1509
4. Database of processing techniques and processing factors compatible with the EFSA food
classification and description system FoodEx 2 Objective 3: European database of processing
factors for pesticides in food
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2018.EN-1510
5. List of processing factors to evaluate pesticides residues measured in the Netherlands
https://www.rivm.nl/en/chemkap/fruit-and-vegetables/processing-factors
6. The German Federal Institute for Risk Assessment data collection on processing factors
https://www.bfr.bund.de/cm/349/bfr-data-collection-on-processing-factors.pdf
7. The German Federal Institute for Risk Assessment compilation of processing factors and
Evaluation of Quality Controlled Data of Food Processing Studies
https://www.bfr.bund.de/cm/349/bfr-compilation-of-processing-factors.xlsx

8. Spanish Agency for Food Safety and Nutrition (AESAN) list of processing factor
https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/gestion_riesgos
/LMR_en_alimentos_transformados.pdf
9. Joint Meeting on Pesticide Residues (JMPR) Reports and evaluations
http://www.fao.org/agriculture/crops/core-themes/theme/pests/jmpr/jmpr-rep/en/

10. OECD Guideline for testing of Chemicals, Test No. 508: Magnitude of the Pesticide Residues in
Processed Commodities
https://www.oecd-ilibrary.org/environment/test-no-508-magnitude-of-the-pesticide-residues-
in-processed-commodities_9789264067622-en

11. RIVM, Processing factors for dried commodities, Netherlands, 11 June 2020,
https://www.rivm.nl/sites/default/files/2020-06/20200611_RIVM-
Processing%20factors%20for%20dried%20commodities_v3.pdf

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HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

Food and feed safety, innovation

Pesticides and Biocides

12. Document Nº SANTE/12682/2019 on analytical quality control and method validation

procedures for pesticides residues analysis in food and feed, as applied in its latest version
https://ec.europa.eu/food/plants/pesticides/maximum-residue-levels/guidelines-maximum-
residue-levels_en

13. RASFF WI: Guideline for the calculation of consumer intake and evaluation of the risk for
pesticide residues as applied in its latest version
https://ec.europa.eu/food/system/files/2017-02/rasff_reg-guid_sops_wi-2-2_en.pdf

14. The EU vegetable oil and protein meal industry association (FEDIOL)
https://www.fediol.eu/web/pesticide%20residues/1011306087/list1187970118/f1.html

15. The Souci-Fachmann-Kraut (SFK) database for food composition

https://www.sfk.online/#/home

16. Association of Organic Processors, Wholesalers and Retailers (BNN)

https://n-bnn.de/sites/default/dateien/bilder/Downloads/Conversion_factors_January2017.pdf

17. The database from the European Spice Association (ESA)

https://www.esa-spices.org/index-esa.html/publications-esa

18. Tea & Herbal Infusions Europe (THIE)

https://thie-online.eu/publications.html

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 EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

Food and feed safety, innovation

Pesticides and Biocides

Appendix I
Decision making scheme for assessing MRL compliance

1
Since dilution is expected, the MRL in the unprocessed product covered by Annex I may still be exceeded.

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