3-2-19-2_EN Inf Client Updates EU Regulation v 16.11.

2021 1/4

Client Update: The New EU Regulation

on Organic Farming

1 Introduction
→ After several years of discussion, the new Regulation (EU) 2018/848 was published on 30
May 2018. In member states of the EU, this regulation will come into force from 1st January
2022 on, replacing Regulation (EC) 834/2007.
→ For non-member countries of the EU (so-called "third countries"), there is a three-year
transition period, so that the new regulation will be compulsory only from 1st January 2025
on.

2 Where to find the official texts

IFOAM offers updated links to the relevant EU legal texts at [Link]
we-do/eu-organic-regulation/. When you follow the link from there to the EU website ([Link]
[Link]), try to find the current consolidated version of each text – this will make your
search less confusing, e.g.:

3 The most important changes

3.1 Scope
✓ In addition to non-processed agricultural products and processed products for food, also
some processed non-food products can be certified under the new regulation, as e.g.
essential oils used for cosmetics or other purposes. These products are listed in Annex I to
Regulation (EU) 2018/848.
✓ The new regulation also includes rules for animal species such as rabbits or deer, which
were not covered under the old regulation.
3.2 Compliance instead of equivalence
✓ Except for countries with trade agreements, the new regulation will be binding also for third
countries. Certifiers will no longer be allowed to establish "equivalent rules" for
countries outside the EU. As mentioned above, there is a transition period until the end of
2024 for the implementation of this new system.
3.3 Group certification
✓ The new regulation defines rules for group certification. Meaning that group certification is
allowed not only in third countries, but also inside the EU.
✓ Most of the rules for group certification are very similar to what CERES has established in
internal policies already – but having these rules in the regulation itself, strengthens the
system.
__________________________________________________________________________________________
CERES CERtification of Environmental Standards GmbH; Domicile: Happurg
Tel: +49 (9151) 96692-0; Fax: +49 (9151) 96692-10; Email: info@[Link] ; [Link]
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✓ The group size is limited to maximum 2,000 members. This will be a significant change for
many large groups.
✓ The group itself must be a legal entity. The internal control system (ICS) can still be
organised, e.g., by a processing or trade company, but the group must achieve its own legal
status, e.g. as cooperative or farmer association. Even though in third countries this will be
binding only from 2025 on, certified groups, which currently do not have their own legal status,
should start working on this, because the process may take its time!
✓ The certifier must externally inspect 5% of the farmer group every year and take samples
from a minimum of 2% of each farmer group. This will make certification more expensive,
especially for larger groups.
3.4 Control system
✓ The risk-based certification approach is further strengthened. Among others, it is allowed to
extend the interval between inspections to 24 months for very low risk operations.
✓ As compared to the old regulation, the new system includes very detailed rules, what must
be done in case of different types of non-conformities.
3.5 Prohibited substances
✓ The so-called "non-authorised substances" have become an important topic in the new
regulation. This refers mainly to pesticide residues.
✓ Operators must prevent pesticide residues. This includes the obligation for farmers to
establish buffer zones with conventional neighbours, where necessary. Such rules existed
only in NOP and other international standards so far, and in internal CERES policies. Now
they have become part of the regulation.
✓ When prohibited substances are found, certifiers must stop organic sales by the
responsible operation, until an investigation has established the origin of these
substances. There are detailed rules on how to conduct such an investigation.
✓ The production of processed organic food excludes food containing or consisting of
manufactured nanomaterials.
3.6 Crop production
✓ There are only few changes to crop production rules
✓ The concept of crops in close connection to soil is strengthened in the new regulation.
There are only few exemptions for plants in containers.
✓ If organic plant propagation material is not available, a derogation must be requested for
using conventional propagation material before planting or sowing. In the old regulation,
this rule applied only to seeds – now it applies to all kinds of propagation material.
3.7 Allowed substances
✓ Use of (non-organic) natural flavours is restricted to maximum 5%. The natural flavour
must be made from the fruit or product it has its name from: 95% of a "natural strawberry
flavour" must be made from strawberries.
✓ There will be a restricted list of products for cleaning and disinfection allowed in organic
processing. As of now, this list does not yet exist.
✓ Chitosan is now officially allowed for crop protection
✓ Calcium hydroxide now allowed for crop protection without restrictions (in the past only for
control of Nectria)
✓ "Cerevisane and other products based on fragments of cells of micro-organisms" (non
GMO) now allowed for crop protection
__________________________________________________________________________________________
CERES CERtification of Environmental Standards GmbH; Domicile: Happurg
Tel: +49 (9151) 96692-0; Fax: +49 (9151) 96692-10; Email: info@[Link] ; [Link]
 3-2-19-2_EN Inf Client Updates EU Regulation v 16.11.2021 3/4

✓ Ethylene – for whatever reason, the authorisation for flower induction in pineapples has
been removed
3.8 Allowed conventional ingredients in multi-ingredient organic products
Considering the availability of most ingredients from organic origin, the list of allowed
conventional ingredients (Annex V(B) to Reg. (EU) 2021/1165) is now restricted. Annex IX of
Regulation (EC) 889/2008, however, will be valid until 31.12.2023.

4 Where to find important subjects

Regulation (EU) 2018/848 is the base standard, for which the European Parliament and the
European Council are responsible. Many details, however, are defined in so-called "secondary
legislation", composed of "delegated regulations" or "implementing regulations", for which the
European Commission is responsible. As of now (8 Nov. 2021), some of these rules are still missing.
The number of such "secondary acts" makes the current situation very confusing – but the
Commission promised it will work on consolidation of some of these rules in the course of the next
months. Here is an overview of where to find the most important rules in the current legal framework:

Topic In Reg. (EU) 2018/848 In delegated / implemen-

ting regulations
General obligations operators Art. 39 2021/1691 (Recordkeeping by
organic operators)
General production rules Art. 9 – 11
Substances allowed in 2021/1165
organic production and
processing
Conversion rules Art. 10 2020/464: Art. 1
Plant production rules Art. 12, Annex II (Part I) 2021/716: Annex (1) (sprouts)
Seeds and plant propagation Art. 13, Art. 26(1) 2020/464: Art. 25
material
2020/1794
2021/1189 (heterogeneous
material)
Livestock production rules Art. 14, Annex II (Part II) 2020/464: Art. 2 – 21
Beekeeping Annex II (Part II, especially
1.9.6)
Aquaculture (including algae) Art. 15, Annex II (Part III) 2020/464: Art. 22
2021/716: Annex (2)
Processed food Art. 16, Annex II (Part IV) 2020/464: Art. 23
Processed feed Art. 17, Annex II (Part V) 2020/464: Art. 24
Wine Art. 18, Annex II (Part VI)
Yeast Art. 19, Annex II (Part VII)
Rules for collection, Art. 23, Annex III
packaging, transport and
storage

__________________________________________________________________________________________
CERES CERtification of Environmental Standards GmbH; Domicile: Happurg
Tel: +49 (9151) 96692-0; Fax: +49 (9151) 96692-10; Email: info@[Link] ; [Link]
 3-2-19-2_EN Inf Client Updates EU Regulation v 16.11.2021 4/4

Topic In Reg. (EU) 2018/848 In delegated / implemen-

ting regulations
Obligations when there is a Art. 27, 41 - 42 2021/279: Art. 8, Annex I
(suspicion of) non-compliance
Precaution to avoid non- Art. 28 - 29 2021/279: Art. 1 - 2
authorised substances, steps
in case non-authorized
substances are found
Use of terms referring to Art. 30 – 33, Annex IV and V 2021/279: Art. 3
organic production, labelling
2021/642
Certification and control Art. 34, 37 – 38, 40 2021/771: Art. 1
system
2021/1342, 1697, 1698
(Recognition and supervision of
control bodies in third
countries)
2021/1378: Art. 2 (List of
recognised control bodies)
Additional inspections, 2021/279: Art. 7
sampling
Certificate Art. 35, Annex VI 2021/1006
2021/1378: Art. 1 (certificate for
third countries)
Group certification Art. 35 (1) (b) 2021/279: Art. 4 – 7 & 10
Art. 36 (1), (2) 2021/715: Art. 1
Art. 38 (1) (d) & 4 (d) & 9 (d) 2021/771: Art. 2
Export of organic products to Art. 44
third countries
Import of organic products Art. 45 - 49
from third countries

__________________________________________________________________________________________
CERES CERtification of Environmental Standards GmbH; Domicile: Happurg
Tel: +49 (9151) 96692-0; Fax: +49 (9151) 96692-10; Email: info@[Link] ; [Link]