Photo of Katharina Ewert

Katharina Ewert

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing regulatory environment. Katharina is a member of Covington’s Diversity and Inclusion Committee.

In her work with a broad range of life sciences companies, Katharina regularly:

  • advises clients on all aspects of food development and marketing, including the regulation of ingredients, labelling and advertising;
  • provides strategic advice to major companies in the medicines and device space on national and EU public procurement considerations;
  • counsels clients on the protection of trade secrets and commercially confidential information, including in connection with freedom of information requests;
  • assists clients in navigating the implications of Brexit;
  • helps companies in evaluating marketing claims for cosmetics; and
  • represents clients in administrative proceedings in the national and EU courts.

Katharina’s pro bono work includes providing regulatory advice to charities and other non-profit organizations.

Katharina gained valuable experience during a secondment the in-house legal team of a global pharmaceutical company.

EU justice
European Union Law Scales of Justice

In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods.  The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.”  Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. 

1. Background

Regulation (EC) 1925/2006 governs the addition of vitamins and minerals and of certain other substances to food (the “Fortification Regulation”).  Article 8 permits the Commission on its own initiative, or on the basis of information provided by Member States, to prohibit, restrict or place under scrutiny “substances” and “ingredients containing a substance”, which are “added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.

In 2016, the Commission, relying on Article 8, requested EFSA to provide a scientific opinion on the safety of HADs and preparations containing HADs.  In November 2017, EFSA adopted its scientific opinion “Safety of hydroxyanthracene derivatives for use in foods” (“the EFSA Opinion”) in which it concluded as follows:Continue Reading EU Court Overturns EU-wide Botanical Food Ban

As with its decision to implement a ban on cigarette smoking in public places, Ireland is ahead of the EU curve on the issue of requiring warning labels to be placed on alcohol products.  With 72% of Irish consumers welcoming the initiative and the EU Commission recently giving it a green light, it seems likely that Ireland will press ahead with enforcing the measure.

Some background

Section 12 of Ireland’s Public Health (Alcohol) Act 2018 includes a provision requiring health warning labels to be placed on alcohol products. In June 2022, Ireland took first steps towards implementation of that provision by notifying the draft Public Health (Alcohol) (Labelling) Regulations 2022 (the Draft Regulations) to the European Commission. 

This so-called Technical Regulation Information System (TRIS) notification was required under the Single Market Transparency Directive 2015/1535 (SMTD), which seeks to ensure transparency of technical regulations adopted at a national level and reduce the risk of fragmentation of the single market by creating different marketing standards and requirements at national level.  This is particularly relevant for food labelling, which is harmonized at the EU level, by, amongst others, the Food Information to Consumers Regulation (EU) 1169/2011.  This Regulation requires certain national proposals for technical regulations, such as the Irish labelling proposal, to obtain a TRIS notification to allow Member States to comment on them and if necessary, raise concerns.  There is a three month standstill period following notification during which the notifying country cannot adopt the technical regulation, which is extended by another three months if the Commission or a Member State submits a detailed opinion.  If a detailed opinion is received, the notifying country must inform the Commission of the measures it intends to take to address the issues raised in the opinion.Continue Reading Alcohol Labelling in Ireland

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government
Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector

Over the past months, the Government has regularly  posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019.  The UK Government has now published four notices addressed specifically to UK food and beverage producers outlining its plans for a no-deal Brexit.  The notices emphasise that the Government believes a no-deal scenario is unlikely, and essentially summarise the Government’s policy decision on certain key issues.  Key areas covered by the notices include geographical indications, food labelling and exports of food containing ingredients of animal origin.  These are discussed further below.

Geographical indications (“GIs”)

The Government indicates that it is keen to protect UK products that benefit from a GI, and if no agreement is reached then it intends to set up its own GI scheme.  The Government argues that it will “broadly mirror the EU regime and be no more burdensome to producers”.  Businesses will have to wait until early 2019 for detailed guidance on what it will involve, but the notice confirms the following:

  • The scheme will be compliant with the World Trade Organisation (“WTO”) Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”).
  • All 86 UK GIs currently protected under the EU scheme will automatically be given new UK GI status.
  • The UK would not have to recognise EU GI status anymore.

Producers will need to adjust product packaging/labelling to include the new UK GI logo.

It is unclear whether, following a no-deal Brexit, current UK GIs would still be protected under the EU regime.  The UK Government assumes that existing UK GIs “will continue to be protected by the EU’s GI schemes”, but this is not guaranteed.  If current UK GIs are not protected under the EU regime after 29 March 2019, then UK producers wishing to regain EU GI status will need to submit applications to the European Commission as third country producers.  The notice also highlights that companies should consider applying for EU Collective Marks or EU Certification Marks through the EU Intellectual Property Office (“EUIPO”) or the World International Property Organisation (“WIPO”).

The Government has recently launched a consultation for its proposed GI scheme. Responses may be submitted until 1 November 2018 on the DEFRA website.

Food labelling

The Government’s no-deal Brexit notice on food labelling raises two main issues.

First, labels on products manufactured in the UK would no longer fall within the scope of “EU” as a descriptor of origin.  This applies to both products sold in the UK and the EU.
Continue Reading UK Government Issues “No Deal” Brexit Notices for the Food & Beverage Sector

As we mentioned in our previous reports (here and here), “sufficient progress” in the first phase of the Brexit negotiation could not be achieved before the European Council of October 19-20, 2017 – so the heads of government decided to wait until their next meeting, on December 14-15, to assess whether the second phase, dealing with the future relationship, could be launched.

By the end of November, the UK government made progress on the sensitive issue of the financial settlement, but it took a frantic week of high political drama to finally reach the “sufficient” agreement, just in time (see our post here on her abortive lunch with President Juncker, and the agreement that was reached following objections from Northern Ireland).  British Prime Minister Theresa May was warmly applauded by her 27 EU colleagues when the decision to launch the second phase was made by the European Council on December 14.

The second phase will start formally in February 2018 with a discussion on the “transition period” between the day of withdrawal and the entering into force of the new treaty.  To that end, the European Council adopted guidelines in December (here), and on January 29, the Council of Ministers agreed a new mandate for the Commission negotiator Michel Barnier (here).

The discussion on the future relationship itself will only start later in spring.  The talks will initially concentrate on a political declaration on the framework of this future relationship, which will be attached to the withdrawal treaty.

The Second Phase of the Brexit Negotiations

As is now well-known, the logic for the two-phase approach in the Brexit negotiation stems from Article 50 of the EU treaty. The withdrawal treaty is a specific instrument which should be agreed upon by qualified majority within 2 years after the procedure has started under Article 50.  However, it must take account of the future trade relationship between the remaining EU Member States and the country leaving the EU.  The negotiation on the future relationship, however, will take more time, and will be conducted based on the model of trade negotiations between the EU and third countries, which at the end of the process requires the agreement of all EU Member States, ratified by national parliaments.

The EU therefore split the negotiation of these issues in the separation that posed the greatest political difficulty off into the first phase, with negotiations on the framework for the future trade relationship only beginning in phase two. The end of the first phase, however, does not mean that the negotiation over the past is over.  Numerous technical issues still need to be addressed and the December joint report (see here) will need to be translated into a legal instrument that will form the basis of the
Continue Reading Brexit Negotiations, Phase 2: Transition, Trade, and Trouble Ahead