21 Dec '21
On January 1, 2022, the new European Regulation (EU) 2018/848 on organic production and labeling of organic products (hereinafter: “Organic Regulation”) will come into force. The new Organic Regulation replaces three current regulations.[1] The most important changes of this new Organic Regulation concern the production (provisions) and labeling of organic products. In addition to the new Organic Regulation, a considerable number of implementing rules have already been published. In this article Ferah Taptik and Mirjam Louws provide a brief overview of the most important changes.
The new Organic Regulation was already adopted in 2018 and would initially enter into force on January 1, 2021. In connection with the coronavirus pandemic, it was decided last year for the time being to extend the coming into force of the new Organic Regulation, as well as the terms included therein, by one year. Many of the current rules are more than 20 years old and need to be adjusted to take into account the major changes the EU's organic sector has undergone over the past two decades, the European Commission said.
In view of the enormous growth of organic production, the European Commission believes that the existing patchwork of rules and derogations does not provide sufficient security and safety for this extremely important sector of European agriculture. The simpler and more harmonized approach of the new Organic Regulation could allow the sector to grow even faster and offer more protection to consumers. Implementing Regulation (EU) 2020/464 sets out production rules for various product groups, including food and feed, which are outside the scope of this Article.
The new Organic Regulation includes a number of new definitions, such as ‘preventive measures’, ‘precautionary measures’ and ‘non-compliance’. Also, for example, the definition of ‘economic operator’ has been replaced by ‘operator’[2]: “the natural or legal person responsible for ensuring that this Regulation is complied with at every stage of production, preparation and distribution that are under that person’s control.”
In the field of primary production, the Organic Regulation has been expanded with various new production groups, such as sweet corn, cork, sea salt, beeswax, essential oils and cotton. The production rules for these new groups are communicated through delegated regulations and implementing regulations. For producers of organic products, the use of natural flavouring is more strictly regulated.
The labeling of agricultural products and foodstuffs should comply with the general labeling requirements of Regulation (EU) No 1169/2011, in particular the provisions aimed at avoiding confusion or misleading the consumer. The new Organic Regulation also lays down specific provisions on the labeling of organic products, which aim to protect the interests of both economic operators (correct identification of their products on the market and fair competition conditions) and consumers (the right information to make a choice).
Under the Organic Regulation, processed products can only be labeled as organic if at least 95% of the ingredients of agricultural origin are organic. This also applies to its derivations or diminutives, such as “bio” and “eco”. Indeed, the terms used to designate organic products should be protected throughout the Union and irrespective of the language used in order to prevent their use in the labeling of non-organic products. This protection should also extend to the usual derivations or diminutives of these terms, whether used alone or in combination.
Foods that contain organic ingredients, but do not meet the established limit of 95% of the ingredients, may contain the aforementioned organic terms in the ingredients list to indicate the relevant organic ingredients of the product. However, in the current organic regulation it is not allowed to refer to organic ingredients if the product contains less than 95% organic ingredients.
In the interests of consumer clarity throughout the internal market, since 1 July 2010, the use of the EU organic production logo in the European Union has been made mandatory for all prepacked organic food produced in the Union. This designation must be displayed within the same field of view of the EU logo. In addition, it is possible to use the EU logo voluntarily for non-prepacked organic products produced in the Union and for organic products imported from third countries.
In order not to mislead the consumer as to the organic nature of the whole product, the use of this logo is limited to products containing exclusively or almost exclusively organic ingredients. Its use should therefore not be allowed for the labeling of foodstuffs of which less than 95 % of the ingredients of agricultural origin are organic. Finally, although the catering industry (in the Organic Regulation: institutional kitchens) does not fall under the Organic Regulation and can therefore call products without certification organic, they may not use the EU logo (for example in advertising or on menus).
The new Organic Regulation also lays down how an operator and/or control body should act in case of suspicion of non-compliance with the regulations (Article 27 et seq.). In the current organic regulations, this procedure is regulated in Article 30 Basic Regulation and 91 Implementing Regulation.
Article 27 sets out step-by-step what an operator must do in the event of suspicion of non-compliance. Where an operator suspects that a product it has produced, prepared, imported or has received from another operator does not comply with this Regulation, that operator shall, subject to Article 28(2):
(a) identify and separate the product concerned;
(b) check whether the suspicion can be substantiated;
(c) not place the product concerned on the market as an organic or in-conversion product and not use it in organic production, unless the suspicion can be eliminated;
(d) where the suspicion has been substantiated or where it cannot be eliminated, immediately inform the relevant competent authority, or, where appropriate, the relevant control authority or control body, and provide it with available elements, where appropriate[3];
(e) fully cooperate with the relevant competent authority, or, where appropriate, with the relevant control authority or control body, in verifying and identifying the reasons for the suspected non-compliance.
Article 28, paragraph 1 of the new Organic Regulation further specifies which precautions the operator must take at each stage of production, preparation and distribution to avoid contamination with products or substances that are not authorized for organic production.
If the operator suspects that a product that is intended to be used or placed on the market as organic does not comply with the Organic Regulation because it would contain a product or substance that, pursuant to Article 9(3), first paragraph[4] Organic Regulation is not authorized for use in organic production, the operator takes the same steps as stated in Article 27. The Commission has laid down uniform rules in Implementing Regulation (EU) 2021/279 for the procedural steps operators must follow under Article 28(2)(a) to (e) (and which documents they must provide). It also lays down uniform rules for proportionate and appropriate measures to be taken and evaluated by operators to avoid the risks of pollution.
Article 29 of the new Organic Regulation prescribes which measures a competent authority (or control authority/control body) can/must take in the event of the presence of unauthorized products or substances. Paragraph 1 provides, among other things, that the body immediately carries out an official investigation to determine the source and the cause with a view to checking compliance with Article 9 paragraph 3, first subparagraph and Article 28 paragraph 1: “such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case."
Paragraph 2 states, inter alia, that the product concerned shall not be marketed as organic if the competent authority has established that the operator concerned has, for example, not taken the precautionary measures referred to in Article 28 paragraph 1 or if “has not taken any measures in response to previous requests in the matter from the competent authorities, control authorities or control bodies.”
The procedure that has been set up differently compared to the current organic regulations in the event of suspicions of non-compliance will have a significant impact on factory farming. Because the text is set up differently, this may cause ambiguity. Operators will need to be aware of the steps to follow in the event of a suspected non-compliance (e.g. discovery of a residue)? What are his rights, if any? For example, paragraph 3 of Article 29 provides that the operator is given the opportunity to respond to the results of an investigation conducted by the competent authority. In practice, the discussions between the operator and the regulator (in this case Skal) often focus on the content, notification and scope of the current Article 91 Implementing Regulation (and by extension: the notification obligation[5]). This will probably not be different with the renewed procedure of Article 27-29 Organic Regulation.
The new Organic Regulation will have a major impact on companies as they will be subject to different (and modified) production, labeling and control obligations. For example, because the structure of the Regulation, the text of certain definitions and the measures in case of suspected non-compliance have changed, the Organic Regulation and the implementing rules in the start-up phase may be open to ambiguity and discussion (amongst operators or between operators and regulators). Non-compliance with the obligations of the new Organic Regulation could (as is the case under the current Organic Regulation) also lead to decertification of the relevant party, for example due to the demonstrable use of unauthorized substances or the striking of insufficient precautions, i.e. measures that operators must take at every stage of production, preparation and distribution to avoid contamination with products or substances that are not allowed to be used for organic production according to the Regulation, and to avoid mixing organic and non-organic products. In case of serious, repeated or continued non-compliance, even the company's certificate may be revoked or suspended.
The specialists of our International Trade, Customs and Food Safety & Product Compliance team will be happy to assist you if you have any questions on this topic, or in respect of other issues related to International Trade, Customs or (organic) Food safety/law. Thanks to our many years of experience in the Customs and Food safety practice, we can serve you quickly and effectively. If you have any questions on this topic, or in respect of other issues related to International Trade, Customs or (organic) Food safety/law, please contact one of our team members or contact Marijn van Tuijl (m.vantuijl@ploum.nl) or Mirjam Louws (m.louws@ploum.nl) directly.
[1] Namely: Regulation (EC) No. 834/2007 (Basic Regulation), Regulation (EC) No. 889/2008 on Production Rules (Implementing Regulation) and Regulation (EC) No. 1235/2008 (Import and Export Rules).
[2] Article 3 preamble under 13 Organic Regulation (in Dutch: exploitant in plaats van marktdeelnemer).
[3] Skal has indicated that at least the following information must then be provided: the information and documents about the supplier (the packing slip, the invoice, the supplier's certificate, the inspection certificate for organic products (COI)); the traceability of the product with the batch identifier, the quantities in stock and the quantities sold (mass balance); the laboratory results; the sample form with the time, place and method of sampling; information on any previous suspicions about the unauthorized product or substance in question; any other relevant document clarifying the matter.
[4] This contains further provisions on the production regulations (as well as in Annex II to the Organic Regulation).
[5] Skal uses a reporting guide on its website (both a reporting guide that is valid until 31-12-21 and a reporting guide that will apply from 1-1-22). However, the notifications are identical. It is unclear why Skal has included the same text and reporting guide twice.
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