Due diligence and evidence requirements in the new EU Organic Regulation
Relevance of risk minimisation concepts for organic companies
Dez. 2021. In this article, you will learn about the changes in the due diligence and evidence obligations that organic certified companies will face with the new EU Organic Regulation (EU) 2018/848[1] and how these extended obligations can be implemented in practice.
The duties of proof and due diligence newly regulated
In general food law as well as in organic law, food businesses have certain duties of care and proof to ensure and document that legal provisions are not infringed. With Article 28 of the Regulation (EU) 2018/848[1], the fulfilment of these obligations will soon be much more extensive for all players in the organic value chain.
Your approach in case of suspicion at a glance
- Identification and isolation of the product.
- Check whether the suspicion is justified.
NEW – Focus on precautionary measures: apply risk minimisation concept!
- Do not place the product on the market until the suspicion can be eliminated.
An infringement is defined in the Organic Regulation as "non-compliance with the provisions" of the Regulation or related legal or implementing acts. If there is a suspicion of non-compliance, Article 27 applies, describing obligations and measures in case of suspicion.
Similar to Article 91 of Commission Regulation (EC) No 889/2008[2], the product must first be identified and isolated in the event of a suspected infringement, which may mean blocking the entire batch. Placing the product on the market as such or as a product in conversion is not permitted. It may not be used in organic production, even as an ingredient, until the suspicion can be cleared. In order to do so, Article 27 requires verification. This is where Article 28 comes in: it describes how to eliminate suspicion using defined precautionary measures.
Article 28: Focus on precautionary measures
Article 28 of the new Organic Regulation aims to establish so-called "precautionary measures to avoid the presence of unauthorised products and substances" in organic enterprises. This means that a risk minimisation concept must be established at all stages of production, preparation and distribution. The precautionary measures that the organic enterprise must define according to Article 28 describe how to react in a suspicious situation and what steps are to be taken to minimise the risk. Thus, the elimination of suspicion is only possible if appropriate precautionary measures have been established beforehand. Consequently, the implementation of this article will become a crucial tool for every organic company at all levels of the supply chain.
Example: Avoiding contamination
Article 28 (1) describes that contamination by products or substances that are not authorised according to Article 9 (3) must be avoided. These are listed in Articles 24, 25 and Annex II.
Article 24 describes the authorisation of products and substances for organic production. For example, if the substance is a food additive, the company must follow a 2-step procedure:
- 1st check: Is the additive authorised according to Regulation (EC) No 1333/2008[3]?
- 2nd check: Is the additive authorised under organic legislation? → check Annex II
Article 25 describes non-organic ingredients of agricultural origin, which may also pose a risk of contamination.
In order to identify and successfully minimise the risks of such contamination by non-authorised substances or ingredients, the Regulation states that "critical points in process steps" should be considered. The associated measures should be proportionate and appropriate. From a legal point of view, this is a grey area.
Conclusion: Precaution means systematic risk minimisation
Ultimately, European legislation does not define an exact rule on how the implementation of the required precautionary measures should look in detail. A good way can be to use the so-called OCP (organic control points) concept. Similar to the establishment of a HACCP concept, the risks at organic critical control points (OCCP) have to be identified and control measures have to be defined, regularly reviewed and documented. It is therefore a concept for risk minimisation and not a procedure for the complete exclusion of unauthorised substances and products. To help you with your risk minimisation concept, we have compiled here twelve key questions to determine the specific risk of your organic products.
The implementation of the precautionary measures, as well as all other requirements of the Organic Regulation, are checked and confirmed by the official organic inspection bodies. Precautionary measures and the associated concept are therefore to be considered part of organic certification.
Advice and analysis in line with the new organic legislation
We are happy to answer any questions you may have on the new EU Organic Regulation and to provide you with a comprehensive portfolio of organic-relevant analytical methods. Our expert Anna Fecke is looking forward to your enquiry.
Relevant regulations
[1] Consolidated text: Regulation (EU) 2018/848 on organic production and labelling of organic products
[2] Consolidated text: Commission Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
[3] Consolidated text: Regulation (EC) No 1333/2008 on food additives
