Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2018/0088 (COD)**

**COVER NOTE**

**Brussels, 2 May 2018**
**(OR. en)**

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**AGRILEG 66**
**DENLEG 33**
**MI 313**
**SAN 131**
**CONSOM 128**
**RECH 158**

From: Secretary-General of the European Commission,
signed by Mr Jordi AYET PUIGARNAU, Director

date of receipt: 12 April 2018

To: Mr Jeppe TRANHOLM-MIKKELSEN, Secretary-General of the Council of
the European Union

No. Cion doc.: SWD(2018) 97 final

Subject: COMMISSION STAFF WORKING DOCUMENT Synopsis report
Accompanying the document REGULATION OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL on the transparency and
sustainability of the EU risk assessment in the food chain amending
Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC

[on the deliberate release into the environment of GMOs], Regulation (EC)
No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on
feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings],
Regulation (EC) No 1935/2004 [on food contact materials], Regulation
(EC) No 1331/2008 [on the common authorisation procedure for food
additives, food enzymes and food flavourings], Regulation (EC) No
1107/2009 [on plant protection products] and Regulation (EC) No
2015/2283 [on novel foods]

Delegations will find attached document SWD(2018) 97 final.

Encl.: SWD(2018) 97 final

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EUROPEAN

COMMISSION

Brussels, 11.4.2018
SWD(2018) 97 final

**COMMISSION STAFF WORKING DOCUMENT**

**Synopsis report**

_**Accompanying the document**_

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**on the transparency and sustainability of the EU risk assessment in the food chain**
**amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on**

**the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003**

**[on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation**

**(EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food**

**contact materials], Regulation (EC) No 1331/2008 [on the common authorisation**
**procedure for food additives, food enzymes and food flavourings], Regulation (EC) No**

**1107/2009 [on plant protection products] and Regulation (EC) No 2015/2283 [on novel**

**foods]**

{COM(2018) 179 final}

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**Synopsis report**

**1.** **I** **NTRODUCTION**

This report covers feedback from citizens and national authorities, groups and organisations
(‘stakeholders’) as regards the initiative for a Commission proposal for a Regulation on the
transparency and sustainability of the EU risk assessment in the food chain (‘Commission
proposal’). The Commission proposal would amend Regulation (EC) No 178/2002 which sets out
the general principles and requirements of food law, establishing the European Food Safety
Authority (EFSA) and defines procedures in matters of food safety. For consistency, the
Commission proposal would also amend other sectoral food legislation. The Commission proposal
builds on the findings of the Fitness Check of the General Food Law [1] and follows the Commission
Communication on the European Citizens’ Initiative to “Ban glyphosate and protect people and the
environment from toxic pesticides” [2.]

Citizens and stakeholders had the opportunity to provide feedback on a **Commission roadmap** **[3]**
from 20 December 2017 to 17 January 2018. 20 stakeholders (15 trade and business associations,
four Non-Governmental Organisations (NGOs) and one Member State (MS) authority) and one

citizen submitted feedback.

This was followed by an **open public consultation** (OPC) [4], targeting citizens and stakeholders,
open from 23 January 2018 to 20 March 2018. The OPC received replies from 471 participants: 318
citizens and 153 stakeholders. 18 of the stakeholders had also provided feedback on the roadmap.

The stakeholders that took part represented a variety of sectors: trade and business associations
(39.22 %), companies and groups (14.38 %), NGOs (13.07 %), professional associations (8.5 %),
national/regional authorities (8.5 %), governmental agencies (5.23 %), research institutes (3.92 %),
public bodies (1.96 %), professional consultancies (1.96 %), think-tanks (1.31 %), law firms (0.65
%), EU Institutions (0.65 %), and other (0.65 %). As regards the citizens who took part, 318 replies
came from 26 MS, 10 came from a European Free Trade Association country and five from other

non-EU countries.

Citizens evaluated their level of knowledge of the EU assessment system for food safety and its
regulatory framework as very good (22.64 %), good (33.65 %), sufficient (26.42 %), little (14.78
%) or none (2.52 %). Organisations evaluated their level of knowledge as very good (37.25 %),
good (47.06 %), sufficient (14.38 %), little (0.65 %) or none (0.65 %).

Targeted consultations with specific stakeholder groups also took place. EU-level stakeholder
organisations representing farmers, cooperatives, the food industry, retailers, consumers,
professionals and civil society were consulted in a working group meeting of the **Advisory Group**
**on the Food Chain and Animal and Plant Health** **[5]** . Consultations also took place via the **EFSA**

1 [https://ec.europa.eu/food/safety/general_food_law/fitness_check_en](https://ec.europa.eu/food/safety/general_food_law/fitness_check_en)
2 [https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf](https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf)
3 [http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6265773](http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6265773)
4 [https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en](https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en)
5 - - https://ec.europa.eu/food/expert [groups/ag](https://ec.europa.eu/food/expert-groups/ag-ap/adv-grp_fchaph/wg_2018_en) ap/adv grp_fchaph/wg_2018_en

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**Advisory Forum** **[6]** (national food safety authorities) and the **Commission Expert Group on**
**General Food Law** **[7]** and with the **Scientific Committee of EFSA** **[8]** .

A letter of the European Ombudsman to the President of the European Commission on ensuring the
EU risk assessment model in the food chain is independent, transparent, and allows for meaningful
stakeholder engagement, was also considered.

Feedback received during the consultations was not taken into account if it went beyond the scope
of the Commission proposal.

**2.** **T** **RANSPARENCY OF INDUSTRY STUDIES**

Citizens and stakeholders acknowledged the importance of **public access to the industry studies**
used by EFSA in its risk assessments, with the exception of the business secrets and other
confidential information, as a significant element of ensuring trust in the EU’s food safety risk
assessment. The OPC showed such access as important or very important in 86.8 % of citizen
replies and 88.2 % of stakeholder replies. The information that EFSA makes public on its activities
and contributions was also judged as very important.

Citizens and stakeholders found that **publishing industry studies**, including raw/aggregated data
but excluding business secrets or other confidential information, has a positive or very positive
impact on:

  - enhancing the transparency of the EU risk assessment system: 87.4 % of replies from
citizens, 91.5 % from stakeholders,

  - strengthening consumer trust in the EU risk assessment system: 84.9 % of replies from
citizens, 73.9 % from stakeholders,

  - allowing scrutiny by other scientific and third parties: 81.8 % of replies from citizens, 80.4
% from stakeholders,

  - enhancing the exchange of information on risk among interested parties: 81.5 % of replies
from citizens, 76.5 % from stakeholders.

As consumers may in general lack the scientific knowledge to use these studies, consumer
organisations suggested that trust would depend on other factors, e.g. third-party scrutiny of the

studies.

As regards the **impact of publishing industry studies,** 42.1 % of citizen replies and 21.6 % of
stakeholder replies state that it is important or very important **for competitiveness** ; 56.3 % of
citizen replies and 31.4 % of stakeholder replies state that it is positive or very positive **for**
**innovation** . Furthermore, about 35 % of replies from stakeholders, in this case mainly industry
organisations, state that publishing industry studies will be negative or very negative for both
competitiveness and promoting innovation. Industry organisations commented that there is a risk of
the published data being misuse.

6 [https://www.efsa.europa.eu/en/events/event/180206](https://www.efsa.europa.eu/en/events/event/180206)
7 [https://ec.europa.eu/food/safety/general_food_law/expert_group_en](https://ec.europa.eu/food/safety/general_food_law/expert_group_en)
8 [https://www.efsa.europa.eu/sites/default/files/event/180214](https://www.efsa.europa.eu/sites/default/files/event/180214-m.pdf) m.pdf

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There were different views on the **timing of publishing non-confidential parts** of industry studies
throughout the risk assessment process and the **impact on transparency.** Among citizens, 58.8 %
considered that immediate publication without confidentiality checks would have a positive or very
positive impact, 6.9 % consider it would have no impact and 28.9 % considered that the impact
would be negative or very negative. Replies on the other scenarios related to the timing of
publication do not showed strong polarisation of opinions, with the exception of the option to not
publish industry studies at all: 77.1 % of citizens state that this would have a negative or very
negative impact, with only 4.1 % considering that it would have a positive or very positive impact.
For stakeholders, 71.9 % believe that the non-publication of industry studies would have a negative
or very negative impact and only 1.3 % considered that it would have a positive impact.

In general, industry stakeholders state that the timing of publication could have a negative or very
negative **impact on competitiveness**, in particular if publication happens early in the assessment
process. Industry stakeholders also highlighted the need to avoid unfair use of commercial data.
Some comments from MS authorities reflect on the need to specify what should be considered
confidential in legislation. NGOs commented on the need to review the validity of the
confidentiality claims made in relation to industry studies.

Both citizen and stakeholder replies to the OPC showed that an open registry of studies, the use of
machine readable formats and having different levels of access to studies would be useful or very
useful tools. Regarding the establishment of a register of industry studies, mainly MS authorities
highlighted the challenges as regards applicability outside the EU. Some MS authorities and
industry stakeholders considered that it may have a detrimental impact on EU innovation.

**3.** **E** **VIDENCE FROM INDUSTRY STUDIES**

Most citizens and stakeholders found important or very important the **elements currently in place**
to ensure that the studies provided by industry are sufficiently robust to serve EFSA’s risk

assessment needs.

In general, citizens found that all the **additional measures regarding industry studies** proposed in
the OPC contribute to some or a large extent to strengthening EFSA’s risk assessments; over 75 %
of replies regarding the single measures acknowledged this. Although, in general, stakeholders
showed similar views, some saw certain measures as having different levels of importance. In
particular, industry stakeholders considered valuable to some or to a large extent the possibility for
providing pre-submission advice to individual applicants, while consumer organisations and some
other NGOs considered that it would not contribute very much. The latter also highlighted the need
to ensure the independence of EFSA’s scientific processes. Some MS saw the potentially for a small
value of pre-submission advice in relation to its cost vs benefit analysis.

83.7 % of replies from citizens and by 63.4 % from stakeholders stated that **complementing**
**industry studies with verification studies** would strengthen EFSA’s risk assessment to some or to
a large extent. As regards the financing of these verification studies, a small percentage of both
citizens and stakeholders considered that the costs should be covered by the individual applicant
concerned. The other financing options proposed, i.e. the EU budget, common funding provided by
all industry applicants or a combination of public and industry funding, were considered relevant by

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32.1 %, 27 % and 25.2 % of citizens, respectively. For respondents from the stakeholder group,
these percentages were 47.7 %, 21.6 % and 9.2 %, respectively.

As regards the potential to **re-enforce the audit system used for laboratories** carrying out industry
studies, the majority of both citizens (78.3 % of respondents) and stakeholders (72.6 % of
respondents) considered that this would contribute to some or to a large extent to strengthening
EFSA’s risk assessments. Some MS expressed reservations on the potential added value of this

measure.

Both citizens and stakeholders considered that **allocating more public resources to financing food**
**safety studies** is important for strengthening EFSA’s risk assessment: around 80 % of citizen
replies state that EU or national funding could contribute to some or to a large extent; the figure for
stakeholders is slightly lower. Some NGOs and EFSA’s Scientific Committee supported the added
value of more public resources dedicated to food safety studies.

Discussions with stakeholders highlighted the potential for establishing procedures for open
consultations on data related to the studies submitted by industry as part of authorisation dossiers.
Although this was in general welcomed, some MS authorities and industry stakeholders mentioned
the potential negative impact on the length of EFSA’s risk assessment processes. The latter also
highlighted the potential negative impact on competitiveness and innovation, in particular on new
substances due to risks relating to potential unfair use of disclosed data and concerns over
intellectual property rights.

**4.** **R** **ISK** **C** **OMMUNICATION**

Overall, all consulted parties acknowledged the value of the actions aiming to improve risk

communication.

In the OPC, over a third of citizens consider that **existing risk communication** does not contribute
very much or at all to building trust in the EU’s decision-making process in the food chain. All the
**new measures proposed** as potentially strengthening the consistency of risk communication were
considered by most respondents from both groups to be effective or very effective (between 61.4 %
and 92.2 % of replies). There is an exception to this in the stakeholder group of respondents: some
NGOs (23.5 % of replies from stakeholders) do not consider that including general principles of risk
communication in legislation would be very effective.

Some citizens highlighted the need to avoid complexity and/or confusion in risk communication,
and recommended making it clearer and simpler. Consumer organisations commented on the need
to clearly explain the political choices made and improve the MS involvement in risk
communication. MS acknowledged the need for more coordination among all actors.

**5.** **S** **USTAINABILITY OF THE RISK ASSESSMENT SYSTEM AND INVOLVEMENT OF** **MS**

It was found that the **tools currently available** to support scientific cooperation between EFSA and
MS to a significant extent already engage MS in the EU risk assessment system: over 70 % of
respondents (both citizen and stakeholder groups) found that all the tools described contribute to
some or a large extent.

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Over 40 % of citizen replies disagreed or strongly disagreed with the statement suggesting that **MS**
**are sufficiently involved in EFSA’s work** . There was a similar response from the stakeholder
group. In addition, both citizens (75.2 %) and stakeholders (79.7 %) agree or strongly agree that the
costs of national bodies’ scientific contribution to EFSA’s tasks should be adequately compensated.
Most respondents (over 75 % in both the citizen and stakeholder groups) agreed or strongly agreed
that an increased involvement of MS is important to ensure that EFSA has a large pool of experts
from MS. MS authorities highlighted the importance of incentives when promoting cooperation.
Some MS, industry stakeholders, NGOs including consumer associations, and EFSA’s Scientific
Committee stressed that cooperation with MS needs to respect the independence of the experts in
their contribution to EFSA and the separation between risk assessment and risk management.

As regards **MS being represented in EFSA’s Management Board**, 57.5 % of citizens and 53.6 %
of stakeholders agreed or strongly agreed. However, 27.7 % of citizen replies and 26.1 % of
stakeholder replies disagree or strongly disagree with this statement. Some citizens and stakeholders
(including MS authorities) highlighted the need to clearly separate risk assessment and risk
management and suggested having representation from other stakeholder groups as well. MS
authorities also considered the importance of defining clear roles for the Management Board to
avoid duplication with EFSA’s Advisory Forum.

Elements including EFSA being able to choose excellent and independent experts from a large pool
of candidates, as well as its independence from risk managers (Commission and MS) and from
industry, were found by over 80 % of respondents in both the citizen and stakeholder groups to be
useful or very useful. The possibility of choosing excellent and independent experts from a large
pool of candidates scored higher, with 96.2 % of citizen replies and 98.7 % of stakeholder replies
considering it useful or very useful. Avoiding scientific divergences between the EU and national
levels was considered to be useful or very useful by 72.3 % of respondents from the citizen group;
this equals 79.1 % for the stakeholder group. Over 75 % of respondents from both groups
considered it useful or very useful to avoid duplication of risk assessments between EU and national
levels, and to ensure an appropriate level of resources for EFSA.

Some MS authorities highlighted the need to ensure a proper balance between EFSA’s
independence policies and its links with scientific excellence, and the need to consider incentives to
stimulate the contribution of MS experts to EFSA’s work, including financial and non-financial

elements.

**6.** **C** **ONCLUSIONS**

Overall, in their replies citizens and stakeholders expressed the importance of the elements
addressed by the Commission initiative to improve the EU risk assessment in the food chain. They
also highlighted the need to ensure that the Commission proposal strengthens these elements while
safeguarding the principles on which the EU food safety system is based.

The contributions to the different consultations showed a **need to consider the following** when
preparing the Commission proposal:

  - The earlier the access to industry studies in the risk assessment process, the greater its
impact on transparency.

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  - Safeguarding confidentiality and intellectual property rights is fundamental in order to avoid
hampering innovation and competitiveness.

  - Details on what information from industry studies can be claimed as confidential need to be
clear, and the related claims must be thoroughly assessed.

  - Need for proportionate verification processes on the quality of industry studies as regards
compliance with relevant standards.

  - Potential value of EFSA’s pre-submission advice to industry applicants while fully
respecting the independence of scientific processes.

  - Capacity for more public resources to finance studies on food safety.

  - Need to tackle potential negative impacts of consultations on studies submitted on the length
of the assessment processes. Need to ensure the protection of confidential data and personal

data.

  - Risk communication on food safety can be further strengthened by improving coordination
and involving relevant stakeholders.

  - Further involvement of MS authorities in EFSA’s activities must continue to ensure the

separation between risk assessment and risk management.

  Scientific independence and excellence of experts are cornerstones of the EU risk

assessment system.

  Adequate incentives are needed in order to ensure that EFSA obtains the expertise it needs

from MS.

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