IFOAM EU SGOP proposal for a common EU residue approach for organicVersion: 09-11-10

- Proposals AB 31.5.2010- Discussed on SGOP meeting 5/6-10-10 and suggestions implemented- Comments by BNN implemented 11-10-10- Comments by BIOKAP partly implemented 15-10-10- Comments by EM – Synabio implemented 09-11-10- Comments by BIOKAP implemented 09-11-10

Strategy for this paperIFOAM EU Sector Group Organic Processing (SGOP) discussed half a year this residue paper. At the last meeting of 5-6 October it was decided to finalize the paper with the following purposes:

1. Discuss the paper in IFOAM EU E-board and the IFOAM EU board meeting of 18/19 November

2. Discuss the paper with EOCC boardmeeting (17 November), who decided in June 2010 to bring forward their own EOCC residue policy paper .

3. After agreement within IFOAM Board, send the paper to the Commission (and spread to national representatives of the SCOF).

4. Further discussion with Commission about the responsibility of the costs for analyzing schemes (private/certification bodies) and costs for decertification in case of contaminations where farmer/processor are not responsible.

5. Further discussions with EOCC (and Commission) to establish risk based inspections in regard to residue contaminations, based on the internal /private quality procedures ‘based on systematic identification of critical processing steps’ (art 26.2 of ECC Reg 889/2008).

Introduction/BackgroundOrganic farming is a production system where, instead of using chemical inputs, the farmer relies on a broad range of activities which prevent problems from occurring. It is a system with an absence of pesticides. However, the organic products are produced in a world where pesticides are commonly used. Hence the risk of contamination with pesticides is always there, in the field, during processing and during transport. As well as any sector, the organic sector is vulnerable for fraud. So, beside the risk of contaminations, residues in organic certified crops might also be an indication of fraud.

To secure the integrity and quality of organic certified agriculture, crops, ingredients and processed food, residue-analyses has become the past 10 years more and more part of the quality assurance of more and more private companies and certification and inspection bodies in organic agriculture, trade and food-processing. Different monitoring programs, like the Oko-monitoring from Baden-Würtemberg, BNN residumonitoring by BNN in Germany and BIOKAP residue-monitoring by VBP in The Netherlands show the relevance of residu-monitoring: about 20% of organic crops show traces of residues, mostly below the action level of 10 ppb.Also in Belgium, Italy and France more intensive residue-monitoring has been started by authorities and/or private sector. More and more private companies in EU countries set their own private standards, including very variable levels from on system to another. Since two years an unofficial

Task Force within the SCOF is formed to discuss individual residue-cases. It seems time to really discuss the residue topic on EU-level with all stakeholders and come to a common approach.

With the rising of the daily practice of residue-analysis the organic sector in the EU faces new fundamental questions in regard to the residue topic. Before the issues are mentioned it is essential to keep in mind that organic legislation was originally mentioned as legislation for a process based agriculture and food-processing system and mainly still is. In the discussion about the need for harmonization in the residue-topic, we might make the mistake to transform a more or less private developed action-level into a strict decertification level into the EU legislation. The negative effects of this simple solution might be even worse than the dissatisfying disharmonized situation of this moment. When the action-level would be transformed to decertification level, it can easily happen that the residue-level replaces all other important aspects of organic agriculture. Organic agriculture is a method, which cannot be replaced by the absence or presence of residues under or above a certain level. On the other hand, a good harmonized policy in the EU towards residue contaminations can help the organic sector to assure and develop organic quality where ignorance is in stake, and prevent the downfall of organic integrity where fraud is the case.

Aim of this paperThe aim of this paper is to show the need for a common residue-approach within the EU, which is based on monitoring, research and exchange of information between stake-holders. The paper is providing practical solutions for authorities, certification bodies and private sector to implement the given EU Regulation in regard to ‘critical processing steps’, ‘organic integrity’ and ‘risk of contamination by unauthorised substances or products’.The implementation of a common residue approach in all EU countries should furthermore lead to the following benefits:

1. To prevent contaminations in general.2. To prevent economical damage for all organic stake-holders in general.3. To take decisions based on research knowledge and clear understanding. 4. To improve the communication and cooperation between private companies, certification

bodies and authorities of all EU memberstates about residue contaminations and risk assessment.

5. Establish common understanding about the meaning of residue contaminations.6. To further evaluate and specify the action-level based on monitoring and researchn7. To structure both general communication about the organic approach towards residue

contaminations in general and crisis-management in case of calamities

EU legislation about residue contaminationsIn accordance to article 26 2. of ECC reg. 889/2008 operators have to “..establish and update appropriate procedures based on systematic identification of critical processing steps”. The aim is to facilitate the organic integrity of the products (article 27 3.). In article 26 4. it is specified that in regard to the above mentioned procedure the operator shall; “(a) take precautionary measures to avoid the risk of contamination by unauthorised substances or products.”The operators are obliged to have a strategy in place how to handle contaminates. Further on the obligations given in article 91 1. of ECC reg. 889/2008 the operator has to take actions if he “considers or suspects that a product is … not in compliance with organic production roles,..”.

In order to fulfil this requirement a knowledge based action level for residues is an important tool. Such an action level for residues is to establish on company level or in a shared quality assurance system (obligation in article 26 2.-4.) as a strategy how to handle contamination with pesticides. Above the action level a residue finding is a “suspicion” in accordance to article 91 1. first line.

Issues There is no common accepted residue-approach for organic within the EU. Not between

the EU countries, not between the certifying bodies and not between the private sector. There is no common understanding within the EU about a common accepted action level.

BNN established 10 years ago the so called BNN action value of 10 ppb (with an uncertainty factor of 50%, with recounting tot fresh products in case of dried or concentrated products and some examples). The private BNN approach has been taken over by the private BIOKAP monitoringsystem of VBP in the Netherlands. In France the actions-levels are slightly different. Belgium is the only EU-country with a decertification-level: 1,5 x LOQ of MRL-values in EU directive for substances ( Directive 396/2005).

Between EU-authorities there is no common approach in case of positive results above the action-value. There is even no common approach towards the action-level itself (see above). This results in market-disturbing situations for many organic companies who take residue-monitoring.

There seems to be a tendency the past years, starting in the private sector, taken over by some certification bodies and even taken over by a special Task Force of the SCOF in residue cases, to work with the action-level , which is established by BNN-Germany, and adapted by BIOKAP-Netherlands.

The operators establish their one internal concepts and strategies. The problem of harmonization is still valid.

Between the private labs there is no common residue-norm and some of them take the freedom to disqualify ingredients as organic when a residue is found (under the action-level of BNN-BIOKAP).

Between the customers of the private organic companies there is no common accepted residue-norm: it varies from zero tolerance to absolute ignorance about the topic (and in the last case when something is found to panic).

Zero tolerance is not the way forward, as it leaves no openings for accidental contaminations as well as huge risks for importers of organic produce in case of positive findings.

On the one hand the organic suppliers face customers that demand zero-tolerance on residues while on the other they face certifiers that do not act when serious doubt has risen.

On the one hand the organic suppliers face national EU-authorities that stop import-authorizations and on the other hand national authorities that take no action at all.

There is no common knowledge about the status of contamination with pesticides and of metabolites as proof of active use, not even between respected labs and respected scientific institutes and advisors related to the organic sector.

At last, but certainly not at least there is the issue of economical damage that can occur by findings of residue-contaminations above the action-level and (after research perhaps) decertification of ingredients. Three important remarks has to be placed here: 1. the organic farmer is not well protected in case of decertification; 2. the importer is not well protected, especially in case of import from third countries when goods are paid already, and there is no agreement between certifiers in different countries; 3. In legal sense decisions made by certification bodies and authorities must be ‘proportional’, that means: must be reasonable in regard to the findings. In some cases it can be clear shown that the last has not always been the case. Certification bodies and authorities must be aware of the economical consequences of their measures and this is not always the case.

The above mentioned examples show the lack of common approach and understanding and leads to serious uncertainty and damage for private companies who really try to take responsibility. Therefore it is necessary that a common approach for all EU-countries will be established soon.

The common EU residue approach for organic An EU-wide harmonized residue approach is needed which is carried by the organic

sector itself, the certifiers and both local and EU authorities. It should be a case by case approach and it is essential to have supervision and solve bottlenecks.

The approach should be in a first step based on the BNN-BIOKAP approach:- 0,01 mg/kg as action level (correction with 50% uncertainty, recounting for

concentrated/dried fruit products to fresh product and some exemptions, like bromide).*

- In a second step the action levels must be further differentiated in accordance to the findings and results of residue monitoring activities and scientific evidence. The monitoring databases has to deliver new action levels for specific substances. This differentiation should be dynamic and knowledge based. For harmonization purposes new differentiated action-levels for individual substances should be agreed on international level (both by private sector and certification bodies).

- When the action level is exceeded then the product is blocked (ECC Reg. 889/2008 article 91 1,) at the current part of the chain, and the procedure of contra-analyses starts. When the contra-analyses is also positive, then the procedure of research starts. This means that the certification body who certified the crop has to do research about the background and cause of the contamination. When the background of the contamination can be clarified (scientifically) and the company/farmer who is responsible for the crop is not to blame, the crop can be sold as organic and will not be decertified. When the certifier is not able to proof satisfactory the background and cause of the contamination, then the certifier in the EU country of import decertify the crop and this decision should be taken over by a. the certification body in the country of origin and b. all other EU-countries.

- The certification bodies of a. the country where the contamination is found (and consumed) and b. the country of import in EU are in principle competent to judge together whether the answers of the certification body who certified the crop is consistent and trustworthy or not. If both EU-certifications bodies disagree, than the below mentioned ‘commission of advice’ must decide.

- For all parties involved there should be an international EU-helpdesk of scientific experts which is qualified to judge about a case, when there is no consensus between stakeholders involved.

Furthermore repeatedly findings (more then 3 times) of the same residue(s) in a product from the same origin (organic project of supplier) but with levels below the action level should also trigger doubt about the organic quality and lead to a serious investigation into the cause of the repeatedly findings of the same residue from the same origin.

A commission of advice should be part of the common residue appraoch. This commission should consist of members of the sector (farming, trade, production), certifiers and independent experts. This commission should advise on bigger cases (to prevent both over and under reaction by authorities) as well as the direction of the common policy.

* = The proposal to start with the BNN-BIOKAP approach, which is based on the EU Directive for Baby Food <91/321/EEG>, is not based on scientific evidence. It is proposed for practical reasons, because: 1. It is adapted by most initiatives from private sector, 2. it is dapated by several certification bodies and 3. it is adapted/accepted by several national authorities. As a matter of principle it is impossible to find a scientific proven level that distinguishes between application and unintentional contamination. Pesticide residues have to be interpreted individually because the degradation of pesticides depends on various factors. So an action level cannot tell about the cause of the residue.

It can only give a hint as it is based on experience. The BNN orientation value is an experience value. A decisive proof can only be found by investigation, this underlines the importance of process control as a definition of organic.

Further investigation is needed Norms for findings of multi-residue contamination in one crop below the action-level. Seeds and sowing material needs further investigation in terms of the appropriate action-

level; this investigation has started at the Wageningen University in The Netherlands. Further investigation is needed for the recounting factor for other dried products than

fruits. Further investigation is needed about the position of different metabolites in different

crops as accepted indication of the active use of active chemicals (see Annex A-3). Further specifications are needed for tolerance of residues of substances which are

allowed in organic agriculture.

Concerns A MRL policy within the organic legislation may not become fuel for the anti-organic

lobby: it can give the impression that organic sector starts to allow a certain level of residues while the consumer who thinks he’s buying residue free; hence he gets disappointed. The consumer who expects organic to be free from residues should hence be educated or otherwise there is the risk of losing his interest as buyer.

The implementation of the residue approach for organic should not reduce the control by certifiers to lab testing. Organic may never be reduced to ‘free from residues’.

ConclusionsThe need for a common EU residue approach is urgent for further harmonized development of organic in EU. Maintaining integrity of organic, preventing contaminations, reduce economical risks, implementation of risk based approach by certification bodies based on internal quality systems by private companies, setting international standards for action-values and further differentiation based on monitoring data and research, and off course meting consumer expectations towards organic integrity and quality are the main objectifs to be realized. The common approach proposed in this paper is based on what is actually happening in different countries like Germany, The Netherlands, France and Italy. Only the approach in Belgium is quite different at this moment. We strongly underline that the proposed common approach is based on a case-by-case approach. An international expert-group might be necessary to take decisions in difficult and/or conflicting cases, or for further development and differentiation of the action-value for specific substances.Some points for further investigation and some concers has to be taken in account by the implementation of this common EU approach.

ANNEX A-1: BIOKAP Residue Norms & Procedures

BIOKAP Norms and ProceduresSince November 2008 the Dutch Processing and Trading Association VBP, started the monitoring program BIOKAP, in order to have better supervision and solve bottlenecks. Etc. etc As VBP we established with Skal certification-body a residue-approach that is based on the BNN approach: a norm of 10 ppb ( 0,01 mg/kg) as action level for investigation, after correction with 50% uncertainty and recounting for concentrated/dried fruit products to fresh product. When the action value of 10 ppb is exceeded the company has to set the product on hold. A second analysis can be done. In case the result of this second analysis is negative (below 10 ppb) further investigation has to be done. The first positive value will not be published in the BIOKAP database. In case the result of the second analysis is positive the company will inform the VBP and Skal. VBP will inform the certifier and supplier and ask for a explanation. the target for this procedure is two weeks. In the case of a positive value Skal will take action conform her statues and procedures. This will lead to possible decertification of the product. VBP will inform the BIOKAP members during this procedure. The target to come to a conclusion is a period of 6 weeks.

Examples 1) Dodine, found in dried apricots in several analysis harvest 2008 between 0 to 0,02 mg/kg (after correction)• Investigations and consultancy advice• Consultancy: might be caused by fraud, but not certain (could also be caused in the fields

or in contaminated water for cleaning) • Decision: decertification of lots above 0,01• Practice: only import of analyzed lots and extra attention harvest 2009

2) Chloorprofam in potatoes, several analyses 2008 between 0 to 0,05 mg/kg• Start investigation in whole chain• Problem traced in pack-stations (where conventional and organic are combined)• Contamination on the packaging lines • Actions taken by pack-stations to prevent contamination• Conclusion: cross-contamination where conventional and organic are combined. No fraud

3) Metabolite found in cumon seed, april 2009 • Investigation: period of 6 months• Two of three labs don’t consider this metabolite as proof of use of residue. One does.• Conclusion external advice: might be proof of use• Decision: decertification of the lot(s) and stop of import-authorization by Dutch

government• Further developments:

practical all cumin seed of different countries show the same contamination, specially India

Germany, France, Denmark and UK follow the decertification at BioFach After new information Dutch government stops all import-authorizations for

company involved; not followed by other countries • Market consequence: distinction between private companies and authorities who accept

cumin-seed with-without this metabolite (and other products from same supplier) = market disturbance

• Juridical complaint by BIOKAP members to Dutch authority

Annex A-2: Press release BIOKAP February 2010

PRESS-RELEASE Nürnberg, 17 February 2010

Results BIOKAP residue-monitoring 2009:Harmonization residue-approach on EU-level needed

The results of the Dutch quality and residue-monitoring system BIOKAP in 2009 show that residue-contamination is a serious harmonization topic for the organic sector in- and outside the EU. The good news is that 81,2% of all analyses are absolutely free of residue-contaminations. This means 18,8% show values above the detection-limit. Of the total amount of 901 analyses 2,9% contains residues above the action-value. This is more or less in line with the Öko-monitoring of the Baden-Würtemberg.

The most striking conclusion is in the field of follow-up decisions by boarder-crossing cases. Between EU-authorities there is no common approach in case of positive results above the action-value. There is even no common approach towards the action-level itself. This results in market-disturbing situations for many organic companies who take residue-monitoring seriously.The Dutch Processing and Trading Association VBP, founder of the BIOKAP quality system, is after one year experience very positive about BIOKAP. Director Bavo van den Idsert: ‘To meet the consumer expectations and to maintain high quality of organic it is really necessary to pay attention to the residue-contamination issue by organic companies themselves and cooperate with the certifying bodies and authorities. Many contamination cases can be easily avoided, for instance by good separation between organic and conventional food-streams from the field to the shop. And in difficult cases it is important to do good research, as happened several times the past year in the BIOKAP program.”

But the first year BIOKAP shows also the weakness of the absence of common understanding and harmonization in the EU towards the residue-topic. Bavo van den Idsert: “There is no common accepted residue-approach for organic. Not between the EU countries, not between the certifying bodies and not between the private sector. As VBP we established with Skal certification-body a residue-approach that is based on the BNN approach: 10 ppb (after correction with 50% uncertainty and recounting for concentrated products to fresh product) as action-level for investigation. On the one hand we face labs (and probably their customers) that demand zero-tolerance and on the other hand we face certifiers that do not act when serious doubt has risen. On the one hand we face national EU-authorities that stop import-authorizations and on the other hand national authorities that take no action. These examples show the lack of common approach and understanding and leads to serious uncertainty and damage for private companies who really try to take responsibility. Therefore it is necessary that a common approach for all EU-countries will be established soon.”

VBP – BIOKAP, www.biokap.com, email: renske@biokap.com

Annex Press release with background BIOKAP

Back-ground BIOKAP- Project of Dutch Organic trade and processing association - Common monitoring database for participants- Started in November 2008- Cooperation with Wageningen University – RIVM and Louis Bolk Institute- Cooperation with Skal certification body- Supported by Dutch authorities (ministry of agriculture, nature and food-quality)- Aim: international cooperation with other organic associations

Targets- Annual 1000 – 1500 analyses - Knowledge based approach to find and eliminate causes for contaminations - Common approach by private sector, certifying bodies and governments - Active approach by private sector for sparring with certifying bodies and governments- Realize pressure on companies (and their certification bodies and governments) where residues

are found- Communication-tool to customers of participants (business-to-business)- Harmonization residue-approach on EU-level

Database product-groups• Grains, rice, maize • Vegetables and potatoes • Fruits • Beans, peas, seeds, nuts• Coffee, tea, cacao, cichorei, carob • sweetening products • Oil and fats• Dairy products and eggs • Herbs and spices

Action value (based on BNN approach) for start investigation– > 0,01 mg/kg = 10 pbb – 50% incertainty– Dried and concentrated fruit factors applied for recount to fresh product

Participants- AgroBioConnection- Ariza- Biofresh- Bakery Van der Westen- Doens Food- Do it - Eosta- Horizon- Machandel - Natudis/Wessanen- Naturelle - Organic Flavour Company - Simon Levelt- Stichting Skal - Tradin - Udea - Vitalis - Yarrah

Annex A-3: Metabolites

Need for fraud prevention is rising; unclear status of metabolites must be solved

The international oriented organic trade and processing companies face more and more problems about the uncertainty with the integrity of organic ingredients that are offered on the international market. There are two main reasons:

1. The growth of organic sales during the last years.2. The participation of retail with very strong demands about residue-free products

The time that purchasing companies could trust on organic certificates only is already far behind us. In reaction on this situation the quality assurance measures by organic trade and processing companies is rising fast. Besides the implementation of quality systems, like BRC, the daily routine of residu-analyses and other analysis become more and more implemented in the organic sector. Several trade organizations established their own residue-norms and procedures, like BNN in Germany and VBP-BIOKAP in the Netherlands. Also the certifiers organized in EOCC are working in the direction in establishing norm and procedures.

The fast growth and importance of the analysis to fight against fraud and secure the integrity of organic quality face the organic sector with new challenges in an area which is knowledge driven and for companies very sensitive (in the way it is interpreted). This can best be illustrated by the recent case of Cumin seed from Turkey (and India). In this recent case several residue-compounds were found and one metabolite called 4-IPA. In this case a technical discussion appeared whether the metabolite 4-IPA was a proof of active use of the substance Linuron or not. Besides that several labs which are fully established in organic sector as trustworthy labs for organic products, appeared not to be able to analyze on this substance. It took about 7 months of investigation to get a clear decision by the authorities.

From the perspective of the good-willing and more and more analyzing organic trading and processing industry it is necessary to learn much more about the legal and practical implications of the presence of metabolites in organic products. Which metabolites (on which crops) are accepted as clear evidence for active use of the original substance and which are not? For organic industry this would set clear and practical international standards to fight fraud and ensure integrity of organic ingredients.

Bavo van den IdsertVBP-BIOKAPwww.biokap.com

ANNEX B-1

Contaminants analysis results data-base and monitoring program for French organic sector

To ensure organic sector integrity by contaminants ‘management and associated risks’ prevention

Current situation in France and discussion status at national level

Until now, there is no harmonization of residue interpretation and policy in France. Authorities and each certification bodies have its own system and sanctions procedures.

Discussion started in February 2010 at national level within French national organic regulation committee of INAO (National Institute of origin and quality sign) in order to define a common national residue policy with harmonized residue limits. The global objective of the work is to define national guidelines in terms of actions and sanctions in case of pesticides contamination detection in organic products, taking into account risk analysis and pesticides contamination level.

To meet this objective, three task forces were set up to work on following topics in year 2010: (1) Definition of normalized sampling methodology(2) Definition of national guidelines for pesticides analysis risk criteria in order to define what is an

“adventitious and technically unavoidable presence” of pesticides(3) Harmonization and definition of residue certification limits

SECURBIO data base project will contribute to the development of task forces (2) and (3) works.

Context and SYNABIO’s previous works

Between 1997 and 2008, SYNABIO (French organic trade association) studied residues analyses reports collected from its members and from French certification bodies on 1993-1997 period for the first study made in 1997 and on 2005-2007 period for the most two recent studies made in 2007 and 2008 especially on organic crops, fruits and vegetables. In 2007, 1988 analysis results were collected on organic crops products. In 2008, 2614 analysis were collected on organic fruits and vegetables.

SYNABIO’s objective is to improve internal analysis control plans set up by organic processors and to give a picture of current status of organic products contaminations by pesticides in France. These inventories proved out that further actions could be carried out in order to support effectively organic sector in the step of permanent improvement of organic products quality.

In 2010, it was decided that ITAB (French organic farming research institute) took over the pesticides contaminations monitoring project as it appeared clearly that challenges and interests of this project on contaminants were oriented towards whole organic sector.

Since the beginning of 2010 and based on SYNABIO’s previous experiments, ITAB started to development a data-processing tool in order to perpetuate the data collection and treatment work which has beeen achieved by SYNABIO until then.

General presentation of SECURBIO programThe SECURBIO project has the objective to develop methodology and tools in order to improve understanding and management of pesticides and GMO contaminations in organic crops products.

The SECURBIO project should lead to following opportunities and benefits:

- to prevent contaminations and downgrading of organic products. Indeed, today when an organic product is contaminated by pesticides and a fortiori by GMO, it is generally downgraded, which means that it cannot be certified as organic and is sold on the conventional market with the associated economic loss for producer or processors

- to define collectively harmonized limits and relevant thresholds linked to product/ substance couples for the interpretation of the results of analyses and the adoption of relevant corrective actions and/or sanctions to be undertaken in case of contamination.

- to improve the relevance of investigations by development of contamination follow-up procedures in order to secure information flow related to contamination cases and to optimize management of the analyses carried out by the companies but also certification bodies

- to anticipate and structure crisis management by building relevant procedures (relevant documentary filing, localization of documents resources, lists of the members of the crisis cell, etc),

- to disseminate recommendations aiming to avoid or at least to limit the adventitious contaminations. These recommendations will also detail specific molecules that should be researched regarding the risks for each type of products and sector

The consequence and benefit awaited are the integrity of organic plant products and the release on the market of organic products free from residues in conformity with consumer’s expectations.

Objective of SECURBIO program in 2010

The objective of the first year is to make of a computer tool prototype for the collection and the monitoring contaminants analysis results. This tool is exclusively dedicated to organic products.

ITAB (French organic research institute) and SYNABIO (French organic trade association) are responsible of this part. The first year of the project was co-financed by Agence Bio (French organic umbrella).

Results and deliverables of SECURBIO program expected for 2010

1. Document mentioning precise specifications of the computer tool 2. Procedures to use of this tool3. The tool prototype4. Tool testing and assessment by capturing and processing existing analyses already collected

before 5. Tool testing by partners sources of analysis reports 6. Definition of complement modules in a view to improve the tool thereafter

Future of SECURBIO program on 2011-2013 period

SECURBIO project development will carry on below 2010.

Indeed, SECURBIO project will be co-financed for 3 years by French authorities from 2011 to 2013.

In order to consolidate and develop further on the SECURBIO data base project, many partners are involved at national level (authorities, technical institutes, organic professional associations...).

ANNEX C-1

BNN paper???