Management Plan 2021 DG Health and Food Safety (SANTE) - europa.eu

 
Management Plan 2021 DG Health and Food Safety (SANTE) - europa.eu
Ref. Ares(2021)249983 - 12/01/2021

Management Plan 2021
  DG Health and Food Safety (SANTE)

                                  EUR [number] EN
Management Plan 2021 DG Health and Food Safety (SANTE) - europa.eu
Contents

INTRODUCTION ........................................................................................................................................................ 3
PART 1. Delivering on the Commission’s priorities: main outputs for the year ...................... 5
PART 2. Modernising the administration: main outputs for the year........................................ 36
    A.      Human resource management ...................................................................................................... 36
    B.      Sound financial management ........................................................................................................ 37
    C.      Fraud risk management .................................................................................................................... 38
    D. Digital transformation and information management ...................................................... 40
    E.      Sound environmental management ............................................................................................ 42
    F. Example(s) of initiatives to improve economy and efficiency of financial and non-
    financial activities .......................................................................................................................................... 44
ANNEX: Performance tables ........................................................................................................................... 45

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Management Plan 2021 DG Health and Food Safety (SANTE) - europa.eu
INTRODUCTION

2020 showed how action on health at EU level can be decisive both for our societies and
for our economies. The mission of the Directorate-General for Health and Food Safety (DG
SANTE) is to strive to protect human, animal and plant health, promote a high level of food
and animal feed safety, contribute to the Union’s efforts to ensure sustainable food
systems and enable the health and food sectors to achieve their full economic potential. Its
work is, by definition, highly impacted by external factors such as human and animal
pandemics.
2021 will focus, as announced by President von der Leyen in her State of the Union
address, on the first building blocks of a strong European Health Union, borne out of the
lessons learned from the COVID-19 pandemic and aiming to strengthen the “European way
of life” (General Objective 2 of this Management Plan). In addition to work on the proposals
for a Regulation on serious cross-border threats to health, and for revised mandates of the
European Centre for Disease Prevention and Control and the European Medicines Agency,
the preparations for the establishment of the EU Health Emergency Response Authority
(HERA) will be key.
The first milestones under the Pharmaceutical Strategy to ensure Europe’s supply of
affordable medicines for citizens and a stronger position as a global innovator and leader,
the presentation of Europe’s Beating Cancer Plan and the launch of the European
Health Data Space will complete the main elements of the Health Union in 2021.

DG SANTE will continue to support EU, Member State and global efforts to secure access to
– and rollout of - safe and effective COVID-19 vaccines, and, more generally, to
strengthen cooperation against vaccine preventable diseases, improve communication on
the benefits of vaccination and tackle misinformation.
The COVID-19 pandemic has made DG SANTE’s efforts to fight antimicrobial resistance
(AMR) even more relevant, including the implementation of the EU’s “One Health Action
Plan”, and important actions under our food safety and sustainability policy.
The new EU4Health Programme, managed by DG SANTE and supported by the Health
and Digital Executive Agency, with a significantly reinforced budget for 2021-27
(EUR 5.1 billion), will be the main financial instrument to protect people’s health during
health crises and to support the above initiatives and other key public health actions.
DG SANTE will focus on the implementation of the new regulatory framework on medical
devices to protect patients and ensure it addresses new and emerging challenges.

The Farm to Fork Strategy led by DG SANTE, and an essential part of the European
Green Deal (General Objective 1 of this Plan), will continue to be rolled out in 2021, with
the preparation of a new EU legislative framework on sustainable food systems, the
revision of the Sustainable Use of Pesticides Directive (SUD) and of the feed additives
Regulation, the development of an EU code and monitoring framework for responsible
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Management Plan 2021 DG Health and Food Safety (SANTE) - europa.eu
business and marketing conduct, and support to Member States to quantify and reduce
food loss and waste.

Under the Farm to Fork Strategy, DG SANTE will also pursue actions in the area of animal
welfare including labelling, the preparation of legislative proposals for front of pack and
origin labelling and the fight against food fraud.

With major outbreaks of animal diseases such as African swine fever and highly
pathogenic avian influenza in 2020, veterinary measures will account for the largest share
of the EU’s budget for the Food Chain strain of the Single Market Programme
(EUR 1.68 billion for 2021-27), supporting disease prevention, emergency measures, crisis
management and permanent availability of strategic vaccines in EU-funded vaccine banks.
DG SANTE will continue to work closely with Member States to ensure all legislation under
its responsibility in the areas of food safety – including authorisation and approval of
substances - and animal and plant health is regularly updated, properly implemented and
enforced and, where relevant, subject to sound financial management and appropriate risk
assessment and risk management procedures.
In 2021, DG SANTE will also deliver on the Council’s requests under Article 241 TFEU
to prepare two studies on - respectively - the Union’s options to update the existing
legislation on the production and marketing of plant reproductive materials, and the status
of new genomic techniques under EU law.

At international level, DG SANTE will promote global health cooperation, including the global
response to the COVID-19 pandemic, the Farm to Fork Strategy and other EU priorities as
well as global solutions with its trade partners and within international fora. We will
advocate the EU’s “one health” approach and a global agreement on AMR, and lead
global efforts to strengthen health and food systems’ sustainability with best practice
examples, and by pursuing “green partnerships” with like-minded non-EU countries and
Sustainable Food Chapters or provisions in the Free Trade Agreements.
DG SANTE’s work attracts strong interest from citizens, interest groups, professional
organisations, as well as Member States and non-EU authorities. We will place a strong
emphasis on clear and constructive communication, and on stakeholder engagement, to
pass clear and consistent messages.
Following the very substantive developments in DG SANTE’s actions and priorities during
2020, we will work to further enhance the efficiency of the DG, and to deploy the available
resources to best effect.
This Management Plan outlines the DG’s political priorities and planning assumptions for
2021. It follows the priorities outlined in DG SANTE’s Strategic Plan for the 2020-2024
cycle, which was developed on the basis of President von der Leyen’s Political Guidelines
and six headline ambitions, and her mission letter to Commissioner Kyriakides. It also looks
at ways to modernise the DG’s administration functions and improve efficiency and
sustainability.

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Management Plan 2021 DG Health and Food Safety (SANTE) - europa.eu
PART 1. Delivering on the Commission’s priorities: main outputs for
the year

General Objective 1: A EUROPEAN GREEN DEAL

                                    In 2021, DG SANTE’s work on safe and sustainable
                                    food will make a key contribution to the European
                                    Green Deal notably through the first steps in the
                                    implementation of the Farm to Fork Strategy. Safe
                                    and sustainable food is essential for a healthy
                                    population and environment. The EU’s food safety
                                    policy ensures that citizens are well protected and
                                    that the internal market in this sector runs smoothly .
                                    EU food safety and quality standards are an
                                    internationally recognised and respected “trademark”.
                                    We work to improving the sustainability of the food
                                    chain both within the EU and at international level to
make the EU food system a global standard for sustainability.

DG SANTE strives to ensure food and feed safety and sustainability against the backdrop of
external factors such as the increased polarisation and politicisation of discussions around
these themes. In particular, upholding science- and evidence-based decisions and avoiding
further nationalisation and compartmentalisation of the single market represent important
challenges in the accomplishment of the DG’s mandate.

EU funding in the food chain area. Following the adoption of the 2021-2027
Multiannual Financial Framework (MFF), the food chain strand under the Single Market
Programme (SMP) governs EU funding in the food chain area for the 2021-2027 period.
The food chain strand is key to ensure a high level of human, animal and plant health and
safe food, and improve animal welfare and the quality of official controls. In addition to
activities currently financed under the Common Financial Framework (CFF), expenditures
under the food chain programme will also cover new activities related to the Farm to Fork
Strategy. The proposed budget for the food safety programme is EUR 1.68 billion (circa EUR
240 million on average per year).

In 2021, veterinary measures are expected to remain the largest share of the food chain
budget. They will mostly cover disease prevention through veterinary programmes,
emergency measures, crisis management and strategic vaccines in EU funded vaccine
banks.

For plants, phytosanitary measures are becoming increasingly important due to
increased globalisation and trade, and new threats. For 2021, the SMP will continue to

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cover phytosanitary eradication, emergency measures and phytosanitary survey
programmes, which will also include containment and eradication measures.

DG SANTE will continue to support the Member States’ official control activities in
animal health, plant health and food safety through EU databases, alert and notification
tools, activities carried out by the EU Reference Laboratories (EURLs) and centres (EURCs),
implementation of the Better Training for Safer Food (BTSF) programme, and management
of two Member State networks. DG SANTE will continue to verify, through audits, the
performance of official controls in Member States and non-EU countries exporting to the
EU.

In 2021, DG SANTE will contribute to the completion of the inter-institutional process for
the establishment of the SMP and will prepare the externalisation of the food chain
strand to an executive agency (European Health and Digital Executive Agency). In addition,
in 2021 DG SANTE will launch the evaluation of the CFF Programme.

Working in partnership with the EU’s decentralised agencies. DG SANTE’s work is
supported by five decentralised EU agencies: the Community Plant Variety Office (CVPO),
the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the
European Centre for Disease Prevention and Control (ECDC), and the European Chemicals
Agency (ECHA). Collectively, they offer a wealth of scientific resources, expertise and
network opportunities to support scientific evidence-based policymaking. Collaboration
amongst agencies and between the latter and DG SANTE will be crucial in the light of the
“one substance – one assessment” principle featuring in the Chemicals Strategy.

Specific Objective 1.1: Food and feed safety

DG SANTE aims to ensure proper implementation of the extensive legislation in food and
feed safety and animal and plant health, and to simplify it where possible. It takes a “One
Health” approach to preparedness and prevention, integrating human, animal and
environmental health, as well as food and feed safety. The effectiveness of DG SANTE work
on food and feed safety must be assessed against external factors such as the
epidemiological evolution of animal diseases and pest outbreaks, the successful
implementation and enforcement of EU measures by the Member States, and positions and
demands of other EU Institutions.

Ensuring animal health and managing and isolating outbreaks of major animal
disease. DG SANTE manages measures to prevent, control and eradicate animal diseases
transmissible to animals or humans, and requirements for moving animals and animal
products into the EU. One of the most important tasks is ensuring the EU can rapidly isolate
and eradicate outbreaks of major animal diseases, such as African swine fever and
highly pathogenic avian influenza, amongst others.

A new EU Animal Health Law (AHL) will become applicable in 2021. In 2021, DG SANTE
will continue to adopt the necessary implementing legislation. DG SANTE will support
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Member States in their transition to the new animal health legal framework, including
through the Better Training For Safer Food (BTSF) programme.

At the same time, we will continue to adapt the EU legal framework to reflect the evolving
disease situation and provide financial support for measures implemented in EU and
neighbouring non-EU countries, taking into account the Global Framework for the
Progressive Control of Transboundary Animal Diseases (GFTADs).

Due to the late adoption of the SMP, the submission of applications for EU cofinancing of
2021 programmes by the Member States has been postponed. The Commission will
nevertheless be able to ensure the retroactivity of the funding requests once the SMP is
approved.

Preparedness and early response will be strengthened and supported by other relevant
instruments - including audits by DG SANTE, EU Veterinary Emergency Team (EUVET)
missions, BTSF training courses, and EU Reference Laboratories and Centres.

EU support for veterinary programmes accounts for the largest proportion of spending
under the CFF. Under the SMP, the estimated budget for implementing national veterinary
programmes in 2021 is EUR 107 million. EU funds will also be available during crises to co-
fund emergency measures to quickly eradicate and prevent disease spread. The estimated
budget for those is EUR 20 million in 2021.

Preventing plant pests. New threats due to climate change and globalisation have
increased the risk of plant pest infestations. DG SANTE manages the EU plant health
regime under the Plant Health Law (PHL) to protect crops, fruits, vegetables, flowers,
ornamentals and forests from pests and diseases. This law includes rules on moving plants
and plant products within the EU, and a strict regime for imports of plants and plant
products that might host dangerous pests.

In 2021, DG SANTE will follow-up on the high-risk plants provisional ban. The dossiers
submitted by non-EU countries have to be analysed by EFSA. Decisions on their presence in
the list will then be adopted, possibly accompanied by import conditions. DG SANTE will also
produce two reports to be submitted to the European Parliament and Council by the end of
2021 as required by the PHL: one on the enforcement and effectiveness of import
requirements, and the other on the experience gained from the extension of the plant
passport system to all plants for planting. Detailed and up to date containment measures
will be put in place for specific pests.

DG SANTE works proactively to detect early, notify, contain and eradicate pests found
in the EU. Prevention, preparedness and management of plant health crises will remain a
core part of our work in 2021, as well as the management of interceptions/outbreaks (e.g.
Citrus black Spot, Xylella, Pine Wood Nematode, Anoplophora, Spodoptera). We will update
the lists of quarantine pests, regulated non-quarantine pests, permanent import
requirements, and protected zones.
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DG SANTE will also use the first International Year of Plant Health (postponed to 2021 due
to the COVID-19 pandemic) to raise awareness of EU plant health rules and their role in
preventing plant disease and promoting biodiversity.

The phytosanitary programmes support the earliest possible detection of about 78 and
the eradication of about 11 (corresponding to 45 outbreaks) of the regulated quarantine
pests on EU territory. In 2021, SANTE will fund the eradication, containment and
surveillance programmes against plant pests, subject to budget availability.

Ensuring market access to safe substances and products. SANTE is responsible for
risk management decisions to place substances for food related uses on the market and
ensures an effective and inclusive risk communication. In 2021, DG SANTE will continue to
work on the implementation of the new provisions of the Transparency Regulation, which
will considerably change the landscape of the EU risk assessment in the food chain and
enters into application on 27 March 2021. Preparatory work will also continue in close
collaboration with EFSA, Member States and stakeholders, on the future development of
the general plan on risk communication.

Moreover, through this strand of activities, DG SANTE will contribute to other initiatives
under European Green Deal, such as the Biodiversity , the Zero Pollution and the Chemicals
Strategies. In relation to the latter, DG SANTE’s work on endocrine disruptors, cumulative
effects of chemicals, and the inter-agency collaboration in the light of “one substance one
assessment” will feature prominently.

DG SANTE oversees the authorisation and approval procedures for substances used
in food and feed production and processing. In 2021, we will continue to authorise a range
of substances whose safety has been positively assessed.

These authorisations include: new substances and new uses of already authorised
substances used as food additives, food flavourings, novel foods, and substances used in
plastic food contact materials. In these domains, DG SANTE will also start preparing the
actions resulting from the recently adopted Chemical Strategy.

Moreover, DG SANTE will provide specific risk assessments for non-food ingredients and
materials with support of the Scientific Committees on consumer safety and on health,
environmental and emerging risks. The latter will serve as the tool for Rapid Risk
Assessment for health threats.

DG SANTE will also authorise health claims, generic descriptors, nutrition claims, and the
use of vitamins and mineral substances in specific food categories as per legal obligations.
Regarding the addition of substances other than vitamins and minerals in food, DG SANTE
will continue to examine their safety, whenever necessary, and adopt the necessary
measures to ban or restrict their use based on EFSA scientific assessment.

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New approvals and renewals of previously approved active substances in plant protection
products and biocides will be proposed on the basis of safety evaluations. These will
include decisions on low-risk active substances. In 2021, in the area of plant protection
products, we expect around 15 decisions on new active substances, around 20 decisions on
currently approved active substances, and around 10 decisions on basic substances. While
the process for glyphosate is still ongoing, the scientific assessment to be delivered in July
2021 will raise media attention and require a well-prepared, forward-looking line by the
Commission. DG SANTE will also closely monitor Member States' activities on emergency
authorisations.

For biocidal products, around 20 to 30 decisions on existing and new active substances and
around 16 decisions on EU-wide authorisations for biocidal products are expected.
Moreover, upholding sufficient availability of effective disinfectants as well as giving
support to Member States on the matter will continue to be a DG’s priority in the context of
the current COVID-19 crisis.

SANTE also manages the establishment of statutory limits to the presence of certain
substances. Maximum residues levels (MRLs) for pesticides will be set via Commission
Regulations to guarantee that food placed on the internal market is safe. MRLs are also a
requirement for food imported from non-EU countries so to maintain the same level of
safety for food of plant origin, whether it is imported or produced within the EU. SANTE will
present draft proposals for decisions on around 70 MRL applications for specific crop-
commodity combinations and for the full review of around 20 active substances, as well as
Regulations lowering MRLs for about 20 substances following non-renewal decisions and
expiry of approvals of active substances.

Maximum levels for contaminants in feed and food will also be set via Commission
Regulations based on EFSA opinions. In 2021, it is foreseen to set or review maximum
levels for several contaminants such as acrylamide, ergot alkaloids, opium alkaloids,
ochratoxin A, lead, cadmium and tropane alkaloids. Discussions will begin or continue to set
maximum levels for other contaminants such as deoxynivalenol, perfluoralkyl substances
(PFAS), mineral oil hydrocarbons, 3-MCPD and glycidyl esters and T-2 and HT-2 toxin. These
actions will also feed into the prevention pillar of the Europe’s Beating Cancer Plan and into
the ambition towards zero chemical pollution in the environment of the Chemicals Strategy.

Moreover, DG SANTE will continue to process the already submitted genetically modified
food and feed applications based on favourable opinions by EFSA.

For veterinary medicines, in 2021, we will handle new authorisations (around 15),
referral procedures (around five), renewals of marketing authorisations (around 15
procedures) and about five to ten procedures for setting MRLs for veterinary medicines.

We will propose re-evaluations of authorisations, new authorisations or modifications and
renewal of authorisations of feed additives based on the outcome of safety evaluations,
including 60 confidentiality decisions. This will cover some essential elements, including
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vitamins, amino acids, trace elements, some microorganisms aimed at boosting the
reduction of the use of antimicrobials, as well as new substances to mitigate the impact of
animal breeding in the environment.

At the same time, we will do considerable preparatory work for and proceed with the
adoption of the legislation needed to implement the new EU Regulations on veterinary
medicinal products and medicated feed, to apply from 2022 onwards.

DG SANTE will actively support the identification and prioritisation of relevant needs related
to research and innovation, and will seek to incorporate them into the activities of Horizon
Europe.

DG SANTE contributes to a high level of food safety through better food hygiene and
control of biological hazards. In 2021, we will continue adapting the legal framework on
food hygiene by modifying certain hygiene provisions notably on slaughter on the farm, on
the controls on food of animal origin, import conditions, microbiological criteria and
Salmonella controls.

In particular, DG SANTE will finalise the evaluation of the legislation on irradiation and
consider possible follow-up actions. Furthermore, one of the major deliverables of the 2017
EU Action plan against AMR, a new harmonised AMR monitoring scheme in food, will be
implemented in 2021, for the next seven years. Finally, DG SANTE monitors the occurrence
of food-borne outbreaks and coordinates their management when necessary.

Performing effective, efficient and reliable controls. Strict enforcement of the EU’s
rules on food safety, animal health, plant health and animal welfare is essential to ensure
that our high standards are not compromised.

In 2021, DG SANTE will ensure continued and smooth implementation of the new Official
Controls Regulation (OCR). Based on exchanges with Member States and stakeholders
and on the feedback from the first full year of implementation, DG SANTE will explore in
which respect the new framework may need to be complemented by further delegated and
implementing acts. Importantly, DG SANTE will propose a restricted amendment to the OCR
in order to extend its scope to official controls aimed at verifying the compliance of
imported animals and products of animal origin with the veterinary medicinal products
(VMP) Regulation. The aim is to enable the use of official control activities to support the
VMP Regulation prohibitions against the use of antimicrobials for growth promotion and
yield increase, and the ban against the use of antimicrobials reserved for treatments in
humans. The latter are key elements of the EU policy to tackle antimicrobial resistance
(AMR), in line with the Farm to Fork target of reducing by 50% the overall EU sales of
antimicrobials used for farmed animals and in aquaculture by 2030 (cfr. Specific Objective
1.2). In addition, comprehensive guidance will be prepared to support a harmonised
understanding and implementation of the OCR.

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We will continue to carry out controls including audits, in both EU and non-EU countries
exporting to the EU, to verify that the EU’s high food safety standards are complied with.
Audits are explicitly mentioned in Commissioner Kyriakides' Mission Letter as a crucial tool
to implement and enforce the EU’s extensive legal framework on food safety.

The audit programme for 2021 includes 305 controls in the area of food safety and
quality, animal health, animal welfare and plant health in both EU and non-EU countries.
This includes 175 audits and similar controls, and 130 analyses. However, it is likely that
there may be cancellations or postponements linked to the external factor represented by
the COVID-19 pandemic.

In 2021, DG SANTE will continue to manage enforcement cases and the safeguard cell
(SGC) for EU and non-EU countries.

DG SANTE will exchange views with Member States to ensure coordination and
consistency in applying the official controls legislation, bring forward enforcement matters
and find concrete solutions. This takes place in High Level meetings between SANTE and
Member States’ authorities, technical meetings and the "Better Training for Safer Food"
(BTSF) initiative. As COVID-19 severely curtailed the implementation of the BTSF
programme from March 2020 onwards, DG SANTE has worked towards repurposing
existing contracts to allow for virtual trainings from January 2021. The 2021 budget for
BTSF is approximately EUR 10 million. DG SANTE will continue to manage and expand the
range of courses available through the BTSF Academy e-learning platform.

DG SANTE manages two Member State networks - the Multiannual national control plans
(MANCP) and the National Audit System (NAS) networks. They aim to enhance official
control systems in Member States. For 2021, the priority will continue to focus on the
implementation of the OCR and the launch of the new IT platform for submission of the
Member States’ Annual Reports.

In the context of Brexit, the correct application of controls on imports into Northern Ireland
from Great Britain (or other non-EU countries) must continue to be ensured.
The EU Reference Laboratories (EURLs) contribute to better implementation of EU
legislation in the agri-food chain and the credibility of the food production system. EURLs
will support the Commission and national reference laboratories, helping to provide state of
the art analytical and diagnostic services to national authorities and enforcement bodies.
The 2021 budget for the EURLs is EUR 21 million.

Maintaining well-developed rapid alert systems. Crisis management in the food and
feed sector is supported by a number of well-established tools, notably the EU’s rapid alert
systems. They aim to identify problems early and allow rapid information sharing, response
and effective cooperation. Each year, there are about 15.000 notifications in the RASFF
network, 2000 requests for assistance and cooperation between Member States concerning
non-compliances of which 300 are fraud-suspicion related, and 2 million documents in
TRACES.
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Effective official controls depend on DG SANTE’s implementation and management of the
Integrated Management System for Official Controls (IMSOC) - established by the new OCR
- and integrating the existing Trade Control and Expert System (TRACES) and EU alert
systems (RASFF and EUROPHYT). This integration between food safety and other systems
at national and EU level (such as the EU Food Fraud Network) will allow better data
analysis e.g. for foodborne outbreaks, as of 2021. This will ultimately simplify border
controls and allow full paperless procedures.

                                       Specific Objective 1.2: Sustainable              food
                                       systems – the ‘Farm to Fork’ Strategy

                                       As tasked by President von der Leyen in her Mission
                                       Letter to Commissioner Kyriakides, DG SANTE leads
                                       on the Farm to Fork (F2F) Strategy for a fair, healthy
                                       and environmentally-friendly food system, which lies
                                       at the heart of Europe's Green Deal.

                                      Following the publication of the F2F Communication
                                      in May 2020, the main DG SANTE deliverable under
                                      this Specific Objective is the adoption of a new
                                      legislative framework on sustainable food
systems by 2023. This flagship action will translate the new concepts, objectives and
parameters of food systems’ sustainability in a framework legislation. Preceded by an
impact assessment to be launched in 2021, the new legislative framework will strive to
ensure coherent implementation of the Strategy across different policy areas and full buy-
in from all actors in the food system, citizens, Member States, trade partners and
international organisations. In this context, responding to the high expectations for a
systemic change of food systems and ensuring that the vision of the Farm to Fork Strategy
is accomplished will represent an important challenge for DG SANTE.

Throughout the first half of 2021, DG SANTE will launch a series of programmes on
Euronews, accompanied by an advertising campaign on TV and social media covering the
various aspects of the F2F strategy. In October, DG SANTE will also organise the second
annual conference on the Strategy with a wide-ranging communication and reach-out
effort.

At cross-policy level, in 2021 DG SANTE will continue to work with DG AGRI in bilateral
discussions with the Member States on the elaboration of Common Agricultural Policy
National Strategic Plans (NSPs) having regard to the Commission's country-specific
recommendations.

Reducing dependency on and promoting the sustainable use of pesticides. DG
SANTE will continue working towards reducing dependency on pesticide and stimulating the
take-up of low-risk and non-chemical alternatives for plant health protection. To this end, it

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will pursue actions to achieve the F2F target of reducing by 50% the use and risk of
chemical pesticides and by 50% the use of more hazardous pesticides by 2030.

In 2021, DG SANTE will continue work on the revision of the Sustainable Use of
Pesticides Directive (SUD) based on an ex-post evaluation conducted back–to-back with
an impact assessment of options for change. The revision aims to reduce the risks and
impacts of pesticide use on human health and the environment and improve the availability
and usability of sound data and statistics on the use of pesticides in the EU for evidence-
based policymaking.

In addition, following the adoption of the second SUD implementation Report to the Council
and the Parliament as part of the F2F Strategy package, DG SANTE will continue working to
improve the existing indicators and targets for the reduction and use of chemical pesticides.

DG SANTE will continue targeted SUD-related audits in Member States and organise BTSF
trainings to exchange best practices specifically on Integrated Pest Management (IPM). We
will also continue to work with Member States to deliver actions identified in the
implementation plan on sustainable plant protection.

In addition, in 2021 DG SANTE will review the relevant implementing Regulations to
facilitate the placing on the market of plant protection products containing biological
active substances.

Improving the efficiency and effectiveness of the pesticide legislation. DG SANTE
will work to address the inefficiencies of the pesticide legislation identified in the recent
REFIT evaluation. It will implement the actions outlined in the report to the Parliament and
the Council through non-legislative and legislative action.

We will adapt data requirements for micro-organisms as active substances and adapt
relevant guidance on assessment methodologies to facilitate their market access as low-
risk active substances; adopt a first list of prohibited co-formulants; adapt the
Communication on data requirements for endocrine disruptors and continue to work with
EFSA and the Member States to further develop the methodology for cumulative risk
assessment of pesticides residues. The completion of the revision of data requirements for
pesticides and biocides to obtain the necessary information to identify endocrine disruptors
and cumulative risk assessment are equally important to achieve the aims of the
Chemicals Strategy. We will take into account environmental aspects when assessing
requests for import tolerances for pesticide substances no longer approved in the EU and,
using diplomacy, trade policy and development support instruments, promote the phasing
out, as far as possible, of such pesticides and to promote low-risk substances and
alternatives to pesticides globally.

Reducing the use of antimicrobials in animals to contribute to the fight against
AMR. DG SANTE will capitalise on the new EU Regulations on veterinary medicinal products
and medicated feed to set in motion actions to achieve the F2F target of reducing the
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overall EU sales of antimicrobials for farmed animals and aquaculture by 50%, by 2030. In
particular, in 2021 DG SANTE will continue to prepare and adopt the tertiary legislation
necessary to enable the application of these Regulations as of 2022. The adoption of
tertiary legislation featuring core measures to combat AMR, including those with an
international dimension (e.g. implementation of Article 118 of the veterinary medicinal
products Regulation), will represent a challenge.

DG SANTE will continue to promote vaccination, animal husbandry systems and feeding
regimes, which support good animal health and welfare to reduce the need for
antimicrobials. DG SANTE will also pursue the implementation of the 2017 AMR action plan
and publish the relevant biannual progress report. Two meetings of the “One health”
network of experts will also be organised to coordinate actions.

Fostering the use of innovative and more sustainable feeds. To reduce the
environmental and climate impact of animal production, DG SANTE strives to facilitate the
placing on the market of sustainable and innovative feed additives, as highlighted in the
Commission Work Programme 2021. Based on the evaluation of the feed additives
legislation, an Impact Assessment will be completed and then followed by the adoption of a
legislative proposal by the end of 2021.

DG SANTE is exploring the revision of the feed ban linked to BSE-eradication to allow for a
better use of EU produced materials in the feed of non-ruminant farmed animals. DG
SANTE will also consider options for the use of insects’ proteins in poultry and pig feed.

Reducing food loss and waste. The Commission is committed to reaching the United
Nations Sustainable Development Goal Target 12.3 to halve per capita food waste at retail
and consumer levels by 2030, and reduce food loss across the supply chain. In 2021, DG
SANTE will help drive and reinforce action at national level, notably to curb consumer food
waste, guided by the recommendations of the EU Platform on Food Losses and Food
Waste, whose mandate will be extended.

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Following the introduction of an EU measurement methodology, DG SANTE will work closely
with other Commission services and Member States to implement food waste prevention
measures and continue preparatory work to set the legally binding food waste prevention
targets announced in the F2F Strategy. It will also carry out consumer research on date
marking and launch an impact assessment with a view to eventually proposing revised EU
rules to prevent food waste resulting from the misunderstanding and misuse of these
dates. In addition, SANTE will contribute to the launch of research proposals to investigate
the extent and causes of food losses in primary production put forward under Horizon
Europe. Moreover, in order to mobilise players and promote evidence-based best practices,
DG SANTE will expand its food waste website, creating an EU Food Loss and Waste
Prevention Hub, a new one-stop digital resource centre for information on food waste
prevention.

Finally, cooperation with international organisations such as FAO and the UN Environment
Programme will be pursued in the context of monitoring SDG Target 12.3 and of the second
International Day on Food Loss and Waste (29 September 2021).

Ensuring a sustainable food production that improves the welfare of animals.
Good treatment of animals is an integral part of sustainable food production. In 2021, DG
SANTE will ensure follow-up of the European Court of Auditors (ECA) 2018
recommendations and the EU Parliament resolution1 by completing the evaluation of the
EU Animal Welfare Strategy 2012-2015.

1
    European Parliament resolution of 14 February 2019 on the implementation of Council Regulation (EC)
    No 1/2005 on the protection of animals during transport within and outside the EU (2018/2110(INI))

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We will also pursue specific animal welfare actions foreseen in the F2F Strategy. This
includes a Fitness Check of the animal welfare legislation. The evidence collected will
inform reflection on available options to improve the current legislative framework.
Scientific evidence will be updated with EFSA’s assistance and a stakeholder conference will
be organised. The Commission will also consider options for animal welfare labelling as
a means to contribute to sustainable food consumption. To this end, a study on animal
welfare labelling is being prepared.

DG SANTE will also continue to contribute to the work of the European Parliament
Committee of Enquiry on the protection of animals during transport until completion in
September 2021.

Furthermore, DG SANTE will continue to manage the EU Animal Welfare Platform and to
implement and follow-up regular enforcement activities on animal transport and the
welfare of pigs. A new Platform sub-group will take on discussion on animal welfare
labelling. The Platform mandate ending in 2021,its renewal will also be considered.

In 2021, DG SANTE will continue to ensure the designation, management and coordination
of the network of Animal Welfare Reference Centres. A third Centre, specific for the welfare
of Ruminants and Equidae, will be designated in 2021. It will also manage two major pilot
projects linked to animal welfare - on laying hens and dairy cows; lead a project to improve
controls on animal welfare conditions on EU livestock vessels, in cooperation with DG MOVE
and the European Maritime Safety Authority (EMSA), including the preparation of derived
legislation.

DG SANTE will also produce an overview report on its two-year project on the use of animal
welfare indicators, which included audits to seven Member States. This report will
contribute to the reflection on available options to improve the current legislative
framework within the F2F Strategy and to addressing one of the ECA recommendations.

Finally, SANTE will adopt a Communication torespond to the European Citizens’ Initiative
“End the Cage Age”, which aims at ending the current treatment of farm animals kept in
cages and at proposing legislation to prohibit the use of cages, farrowing crates, sow stalls
and individual calf pens for several animal species.

Fighting against food fraud. Combating food fraud is essential to protect the safety and
quality of EU food products, to protect consumers and ensure sustainable food systems.

The EU Food Fraud Network will continue to coordinate responses to suspected food fraud.
DG SANTE will continue to work with Member States, other relevant DGs, OLAF, EUROPOL
and INTERPOL to ensure better cooperation and coordination of national investigative
services, and to ensure effective data analysis and intelligence sharing at EU level.

The Official Control Regulation (EU) 2017/625 introduced a new provision, which foresees
that Member States should put in place controls aimed at identifying and following-up
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fraudulent or deceptive practices. DG SANTE plans to carry out audits to five Member
States in 2021 to verify the implementation of this provision.

Empowering consumers to make sustainable and healthy food choices through
the provision of food information. DG SANTE will work to improve consumer
information, notably by looking at ways to address demands for more visible and complete
information, especially on the health benefits and sustainability of food products, which will
be promoted through labels and digital tools.

DG SANTE will continue to ensure implementation of the rules on food information to
consumers (Regulation 1169/2011). It will continue to operationalise a Food Labelling
Information System encompassing all EU labelling indications to support food business
operators. In food labelling, DG SANTE will start working on the Impact Assessment on
Front of Pack nutrition labelling/nutrient profiles, on origin labelling of certain
products and date marking with a view to the subsequent adoption of legislative
proposals. Moreover, DG SANTE will launch preparatory work on the sustainable food
labelling framework. In particular, it will conduct a study on consumer behaviour and
understanding of food sustainability labelling, to be finalised in 2022.

DG SANTE will further work on the implementation of Regulation (EC) 1925/2006 on the
addition of vitamins and minerals and of certain other substances to foods. In this context,
it will launch preparatory work, including an Impact Assessment, on the Commission
Regulation setting the maximum amounts of vitamins and minerals added to
foods, including food supplements.

Finally, we will continue working on the implementation of Regulation (EU) No 609/2013 on
foods for specific groups. In this context, DG SANTE will prepare a draft delegated act on
compositional requirements for baby food.

Supporting innovation in the food chain, especially via the promotion of novel
food, plant reproductive materials and innovative techniques. DG SANTE will
facilitate new opportunities under Horizon Europe to deliver new knowledge and data to
support the F2F Strategy on food waste, find alternatives to antimicrobials and synthetic
chemical pesticides and improve access to healthy diets.

In the field of novel food, authorisation applications processed by DG SANTE (see Specific
Objective 1.1 – Market access for safe substance) cover requests for authorisations of
insects, plant-based proteins and algae-derived products as novel foods in Europe, based
on EFSA’s scientific advice.

On seeds and plant reproductive material, DG SANTE will ensure proper and timely
implementation of the Plant Reproductive Material legislation, certification and marketing
requirements and the Community Plant Variety Rights legislation, including the work carried

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out by the CPVO. DG SANTE will continue to register new improved plant varieties in the
Common Catalogues for marketing throughout the Union.

In addition, DG SANTE will conclude two studies to follow up the Council’s request under
Article 241 TFEU to be completed by end April 2021. One will focus on the Union’s
options to update the existing legislation on the production and marketing of plant
reproductive material. The options identified in the study will be the basis for an impact
assessment for the targeted revision of said legislation. The other study will focus on the
status of new genomic techniques under EU law following the ruling of the EU Court of
Justice.

Improving the regulatory framework on Food Contact Materials (FCM). Food
packaging plays a key role in food systems’ sustainability. DG SANTE will continue to revise
the Food Contact Materials framework legislation, conducting in parallel its evaluation
and the launch of the corresponding Impact Assessment process. In the run-up to the
revision of the Food Contact Materials legislation, we will pay special attention to the
reduction of citizens’ exposure to endocrine disruptors.

In parallel, the Commission will further explore how to best address the migration into food
of various heavy metals from ceramic and vitreous food contact materials. A study will be
completed in 2021, enabling the consideration of health-protective measures to reduce
consumers' exposure to heavy metals. An Impact Assessment, supported by the above-
mentioned study, will also be launched and concluded by the end of 2021.

Linked to the Commission’s work on the European strategy on plastics, DG SANTE will
continue to prepare, with a view to ultimately adopt in 2021, decisions for around 160
authorisations of mechanical PET plastic recycling processes and related targeted
amendment of plastics recycling legislation. This promotes the uptake of recycled plastics
by the food packaging industry, which accounts for a major part of plastic packaging.

Specific Objective 1.3: International promotion of EU food safety standards

DG SANTE will enhance its work with international partners to promote the EU policy
models on safety and quality standards and sustainable food systems, to ensure our
standards are understood and fully respected and safe trade can take place. DG SANTE
steers the Commission’s position in this area and coordinates Member State input to ensure
policy coherence between our internal policy actions and external engagement on the
global stage.

The Green Deal and Farm to Fork call for an ambitious international agenda. DG SANTE will
foster international discussions to promote the shift to sustainable food systems in
multilateral fora and at bilateral level. This work will contribute to the EU achievement of
specific UN Sustainable Development Goals (SDG), especially SDG 2 Zero hunger, SDG 3
Good health and well-being, and SDG 12 Responsible consumption and production. The
international outreach and buy-in of the Strategy will represent a major challenge whose
                                                                                               18
outcome ultimately depends on external factors as non-EU countries may not share the
ambitions of the Green Deal or may have different views to approach this challenge.

Improving multilateral relations. The EU is the largest exporter and second largest
importer of food in the world with a well-recognised and respected framework of food
safety legislation. In 2021, DG SANTE will continue to promote food safety and quality
standards, and the new F2F Strategy through its work in multilateral fora. It will also
promote and support relevant initiatives of the Food and Agriculture Organisation (FAO),
World Health Organisation (WHO) and other UN agencies with specific attention on the
2021 UN Food Systems Summit.

In the context of the World Trade Organization (WTO), DG SANTE will contribute to the
preparation of meetings of the WTO governing bodies and seek to seize other opportunities
to promote the EU regulatory system. In particular, DG SANTE will engage on the global
objectives of the Green Deal on the 12th WTO Ministerial Conference in June 2021. At
meetings of the WTO SPS Committee, DG SANTE will promote and defend EU interests in
the field of sanitary and phytosanitary measures and defend EU legislation on food safety,
animal health and plant health. In particular, it will continue to address the criticisms on EU
policy on pesticides or on the new EU rules on plant health and veterinary medicines in the
area of AMR. The ambitious measures and high standards announced in the Farm to Fork
Strategy will make this task more challenging. DG SANTE will also continue its work in the
context of the WTO Committee on Technical Barriers to Trade (TBT) in certain policy areas,
such as food labelling, halal meat and animal welfare.

In the World Organisation for Animal Health (OIE), DG SANTE defends the EU’s high
animal health and welfare standards and works to influence and promote international
standards. In 2021, DG SANTE will continue to coordinate EU positions within the Codex
Alimentarius and lead or contribute actively to Codex work in priority areas to promote
food safety at international level and ensure as far as possible that EU legislation and
Codex standards are aligned. Special attention will be paid to priority or sensitive dossiers
such as the revision of the code of practice to minimise and contain AMR and a new
guidance on integrated surveillance on AMR by the Task Force on AMR; the discussions and
possible vote on a Codex Maximum Residue Limit (MRL) for zilpaterol (a growth promoter)
where different visions on agricultural production are at stake; the adoption of MRLs for
pesticide residues; the discussions on the front-of-pack labelling and nutrient profiles. The
EU will continue scrutinising the provisions on food additives under discussion to ensure
they fulfil the strict EU criteria and lead the important work on the technological
justification of certain additives used in foods for infants. For the Codex Committee on
contaminants in food the EU positions will be defended, including for cadmium in chocolate
and aflatoxins in cereals and cereal products.

DG SANTE will actively participate and contribute to the intersessional activities under the
Convention on Biological Diversity (CBD) and the Cartagena Protocol on
Biosafety. EU positions and statements will be coordinated and used for negotiations
                                                                                                  19
towards the Conference of the Parties of the Convention on Biological Diversity (COP) and
the meeting of the Parties of the Cartagena Protocol (COP-MOP), to be held in the second
half of 2021. DG SANTE will also contribute to the biosafety component in the post-2020
global biodiversity framework. In the International Plant Protection Convention (IPPC),
DG SANTE will continue to coordinate the EU input on global plant health strategy, including
the development of international standards and guidelines for phytosanitary measures.

At European level, DG SANTE will be intensively involved in the scientific work performed by
the European and Mediterranean Plant Protection Organisation (EPPO) in the
framework of pest risk assessment and pest risk management.

The EU is one of the world’s largest exporters of seeds. International policies on seeds are
important for jobs, food security, to adapt to climate change and ensure sustainable
agricultural production. In 2021, DG SANTE will continue to work towards international
harmonisation and governance in the area of seeds and in particular towards implementing
the OECD Seed and Forest Schemes. It will work to improve cooperation and guidance
within the International Union for the Protection of New Varieties of Plants (UPOV),
and improve access to plant genetic resources and sharing in the context of International
Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA).

Regarding WHO, DG SANTE will engage in implementation of the World Health Assembly
Resolution on strengthening food safety, prepared under EU leadership. It will contribute to
the development of a new WHO strategy on food safety (expected adoption in 2022) and
sustainable financing of scientific advice or the engagement of WHO in the development of
sustainable food systems. DG SANTE will engage in discussions at WTO level on the
commercial aspects of promoting sustainable food systems.

Improving bilateral trade relations. The EU's external trade requires direct engagement
with trade partners to ensure the relevant safety requirements are met to protect health
and prevent trade disruption, as trade is also a performant instrument to promote the EU
Sanitary and Phytosanitary (SPS) system and the F2F Strategy. The main activities planned
for 2021 are to continue negotiating SPS Chapters of the FTAs, to manage, monitor and
implement existing agreements and to negotiate safe, secure and harmonised export
conditions for EU products with non-EU countries. Ensuring trading partners will adopt
proportionate and scientifically justified measures respecting international principles - in
reaction to occurrences of animal diseases in particular (regionalisation) - is also expected
to remain a significant challenge. SANTE will continue working on the cooperation with
trade partners in a horizontal way, through the Partnership instruments and training
programs.

In this area, ensuring smooth trade relations with the UK whilst preserving EU interests is
an additional challenge.

We will continue to promote the F2F Strategy internationally, seeking to build “green
partnerships” with like-minded non-EU countries and exploring the possibility to pursue the
                                                                                                20
inclusion of Sustainable Food Chapters or provisions in the FTAs. DG SANTE will advocate
for a global agreement on AMR and engage with major global players and strategic
partners to achieve the objectives of the WHO global action plan on AMR.

DG SANTE will continue leading negotiations on SPS chapters in the Free Trade Agreement
negotiations underway, or planned, e.g. Australia – New Zealand (deadline end 2020),
Indonesia, Chile, Eastern and South African countries (ESA). It will monitor the ratification
process of the EU-Mercosur Agreement and prepare for the entry into force of the recently
ratified agreements (Vietnam and Singapore). It will contribute to the implementation of
the Withdrawl Agreement with the United Kingdom with regard to SPS requirements for
trade in agri-food products, and seek to update the EU-Switzerland SPS Agreement to
possibly extend its scope to include the entire food safety area. For agreements in force,
DG SANTE will manage and ensure enforcement of those linked to the Eastern Partnership,
the EU-Korea free trade agreement, the EU-Canada Comprehensive Economic and Trade
Agreement (CETA), EU–Japan Economic Partnership Agreement (EPA), the Partnership
Agreement with New Zealand and the agreement with Chile.

DG SANTE negotiations are based on the concept of ensuring fair and balanced market
access, with the EU to be considered as a single entity for export, as it is for imports,
rather than a collection of 27 individual Member States assessed independently. In practice,
this means striving for the EU trading partners to accept EU-wide applications for export,
and to carry out audits based on visits to a representative sample of Member States.

DG SANTE will also aim for successful negotiations of enlargement related dossiers. In
particular, DG SANTE will monitor candidate countries and set benchmarks (North
Macedonia, Albania), assess the fulfilment of the latter (Montenegro, Serbia and Turkey),
and manage the “Green line” Regulation in the context of the solution of the Cyprus
problem. It will also contribute to implementing the Green Agenda for Western Balkans and
to actions aiming to establish sustainable food systems in the region. Furthermore, a
capacity-building project for veterinary services in the Western Balkan countries will be
implemented with the assistance of DG NEAR.DG SANTE will continue to pursue better
bilateral SPS relations with key commercial partners, notably maintaining the technical
dialogue with Russia and Eurasian Economic Union countries, and possibly relaunch the EU-
Brazil SPS mechanism. With regard to mutual recognition, DG SANTE will pursue the second
phase of the bivalve molluscs equivalence determination, and the EU-Japan mutual
recognition project on regionalisation,. DG SANTE will also finalise the revision of the
existing Memoranda of Understanding with China, whilst pursuing work towards the
conclusion on a project on regionalisation. We will also engage in a bilateral dialogue on the
sustainability of food systems.

DG SANTE will also seek to strengthen relationships with the African Union to build up a
better continental integrated SPS regulatory framework and the implementation of
international SPS standards. This can translate into closer trading relations with Africa and

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to support opportunities for sustainable food systems in Africa. It would also allow safer
products to better reach the EU markets.

General Objective 2: PROMOTING OUR EUROPEAN WAY OF LIFE

In 2021, DG SANTE will continue working with Member States on all fronts to tackle the
COVID-19 pandemic. The first priority is to guarantee the health and safety of European
citizens, protecting people from the spread of the virus, supporting health systems and
health workers and facilitating the supply of protective and medical equipment across
Europe, while working towards the development and equitable distribution of COVID-19
treatments, vaccines and diagnostics. Citizen acceptance of public health measures to
manage and respond to the pandemic is essential and a key external factor. As such, public
health measures need to be accompanied by timely communication actions.

Guaranteeing access to high-quality health care is a key objective of social protection
systems in EU countries. For many citizens, health and healthcare are a fundamental part
of how they understand their social fabric and the European way of life. The European Pillar
of Social Rights stresses the right to timely access to affordable, preventive and curative
health care of good quality in Principle 162. In 2021, SANTE will contribute to the
development of the Action Plan for the implementation of the European Pillar of Social
Rights. The EU promotes cooperation among EU countries in this area focusing in particular
on access, quality, resilience and sustainability of health systems, and the coordination of
responses to cross-border health threats, such as the COVID-19 pandemic. In the field of
medicinal products where there is a well-developed EU regulatory framework, DG SANTE
ensures the functioning of the internal market where medicines meet the requirements
relating to safety, quality and efficacy.

EU funding for health. 2021 will see the launch of the EU4Health Programme3 which
aims to protect people’s health during the current health crisis and beyond, by
strengthening health crisis preparedness and coordinated management, improving the
availability and affordability of medicines, medical devices and other relevant products,
and, strengthening health systems and the healthcare workforce in the Member States by
addressing the long-term challenges that health systems, patients, healthcare
professionals and society as a whole, are facing. The programme will also fund actions to
implement Europe’s Beating Cancer Plan and the Pharmaceutical Strategy. EU4Health is

2
    The European Pillar of Social Rights in 20 principles
3
    REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the establishment of a Programme
      for the Union's action in the field of health –for the period 2021-2027 and repealing Regulation (EU) No
      282/2014 (“EU4Health Programme”)
      https://ec.europa.eu/info/sites/info/files/com_2020_405_en_act_v11.pdf

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