– What are the topics the European Commission is focusing on at the moment?

– What other topics are expected in the near future?

– What is Covid-19 impact from the Commission perspective and at the Commission level?

Prof Em. Vera Rogiers
In Vitro Toxicology and Dermato-Cosmetology (IVTD), Vrije Universiteit Brussel
Corona viruses usually infect humans via mouth, nose or eyes by introducing their genetic material in the cells of contact. Virus particles on the hands cannot penetrate trough intact skin, but infection by the hands may occur by touching face and eyes. It is therefore important to effectively destroy, as soon as possible, all virus particles on hands and objects that are regularly touched. This can be done with detergent solutions. The structure and composition of the viral particles play an important role in choosing the active ingredients that are capable of de-risking potential contacts. The question is what are these trustable ingredients? As well soaps as syndets may be used, but most people do not make the difference between both groups of substances. Therefore, the use of tensioactive substances will be discussed making a clear difference between soaps and syndets by providing positive and negative effects of both categories. Also, some relevant examples will be given. When washing hands with tensioactive substances is not possible, disinfection is carried out by using alcoholic solutions. Here too, not all preparations are active against viruses and their performance highly depends on the vol % of the alcohol present. Furthermore, disinfectants that have been tested for their killing effect on bacteria, are not necessarily effective against viruses. Finally, hand creams may play a role in keeping a healthy skin when months of washing hands and disinfection are daily reality.

Over the last few years the Spanish Agency of Medicines and Medical Devices (AEMPS) Cosmetic Unit, has noticed a proliferation of “Zero waste” philosophy shops. In them, cosmetic products can be packaged at the purchaser´s request.
Spanish authorities have concerns on how this activity is being performed by the shops. We are also worried about the information that the customers receive during the sale and on the label of the products.
During 2019 AEMPS developed a Cosmetic Product Market Surveillance Campaign to check the situation, and many infringements were detected.
As a result of this Campaign, AEMPS is preparing a document to help all the implicated agents to develop this activity in the best conditions of quality and safety.
We would like to show some key points of the document in this forum.

– Special focus lately on cosmetics vs. biocides?

– Are there court cases because of wrong classification?

– If a product is “multi-tasking” falling under more regulatory frameworks, what do you do?

– How are claims regulated in EU?

– Types of claims and how to prove them (e.g., safety claims, environmental claims, efficacy claims…)

– Statistics on use of cosmetics claims in EU – do claims sale?

• How to proof a cosmetic claim?
• in vivo or in vitro or ex vivo studies?
• Are tests performed on ingredients enough?
• Is a consumer test enough to proof my claim?
• Good Clinical Practices (GCP) or Good Laboratorial Practices (GLP)? Which Ones are Applicable to Cosmetic Product Testing?

The European cosmetics industry is tightly-regulated via a harmonised set of regulations. Whilst product claims are regulated, and must not be misleading, there is no official definition or harmonised criteria in the EU to substantiate precisely how green claims like ‘natural’ or ‘organic’ are applied to a cosmetic product without being misleading. As Europe transitions to a green and sustainable future, inevitability there is an increasing demand for greater transparency throughout the value chain. NATRUE will outline the existing regulatory framework, new initiatives under development, voluntary label schemes, and other tools available to help orientate cosmetic producers and consumer alike.

Erik will provide an update on the preparations for the application of the new regulations from a Commission perspective also touching upon the priority that is being given to Covid-19 related issues.

National Competent Authorities have several tasks under MDR and IVDR.
Main task for most of them is to conduct effective market surveillance. Helena will
give some examples illustrating challenges the authorities may face when we are
reaching the date of application for MDR and IVDR.

Notified Bodies play a key role in the implementation of the MDR and are the “final step” of
the very long and extremely important “preparation and certification process” of a
manufacturer of medical devices. It is well understood that challenges of the Notified Body
have an impact also on the manufacturer and challenges of the manufacturer have also an
impact on the Notified Body.

Taking this into account, Mr. Klaus-Dieter Ziel, Managing Director of the Notified Body
MEDCERT GmbH gives a presentation on his 4 main challenges, which are 1) initial MDR
audits under COVID-19, 2) the huge number of additional guidance documents which must
be taken into account, 3) the important differences of an MDD compared to an MDR
conformity assessment process and 4) the extremely high number of MDD certificates
expiring in 2023/2024.

The new European regulations have presented the medical device industry with new challenges in order to ensure compliance to the MDR and continue placing medical devices on the EU market.  This session will identify the key challenges experienced by non-European medical device manufacturers in preparing for compliance to the MDR, and the lessons learned and/or strategies being used by medical device manufacturers to address these challenges.

The changes in the scope and classification brought about by the new medical device regulation are evolutionary rather than revolutionary. They mainly reflect lessons learned and technological changes. A significant change is the addition of devices without a medical purpose within the scope of the regulation. The impact of technological change can be seen in the new rules on software, nanotechnology and closed loop systems. The new requirements add to the complexity of compliance and imply the need of guidance. Some of this is already published and more is on its way.

Most Medical Device Manufacturers knows how to structure and analyse related risks, but not many knows how to structure the benefit analysis to be able to complete the Benefit – Risk Assessment. Helene will provide you with a method to structure and analyse this process according to the new medical device regulations.

The Essential Requirements of the Directives have become the General Safety and Performance Requirements in the regulations. The original requirements have been mostly retained, but much detail has been added. New areas have been introduced such as cybersecurity, apps, CMR substances and nanomaterials.

Helene will teach you the overall processes in conducting a clinical evaluation; understand the requirement, the different stages and what other processes are connected to the clinical evaluation process.

Endocrine disruptors (EDs) are xenobiotics able to alter endocrine system homeostasis causing adverse health effects in an intact organism, or its progeny, or (sub)populations. Humans are frequently exposed to one or to a mixture of ED by inhalation, ingestion, and/or dermal contact of several products. Some suspected ED in cosmetics are under the EU lens, because they could increase the source of endocrine disruption in humans. EDs can be included in a cosmetic product as active principles, as a contaminant or as a by-product leached form packaging.

The ED mode of action does not fit to classical linear toxicology trend but shows non-linear trend and it can occurs at several levels of hormone homeostasis: firstly, influencing hormone’s binding to its specific receptor, but also by modifying hormone regulation, synthesis, secretion, transport and degradation. The uniqueness of EDs among all categories of xenobiotic substances imply a brand new strategy for assessing their effect on products used daily by humans. A case by case strategy for assessing safety of ED in cosmetics suggested by Prof. Vera Rogiers (SCCS Co-chair) is in line with ED action. In this scenario, some tests should be mandatory and included in the safety evaluation of all ED compounds in cosmetics.

The possible presence of ED in cosmetics opens a new branch of studies on human exposure, usually not included in classical toxicology, but more related to endocrinology. Therefore, a new role for experts in this field should be considered when evaluating safety of ED in cosmetics.

– Status of the impact assessment on fragrance allergens labelling

– Implications

– Implementation

During these challenging times, the resilience and adaptability of the European Cosmetics sector is a perfect example of an industrial sector resisting, while contributing to society’s wellbeing and even health protection against COVID-19. In spite of the pandemic, a number of activities have been initiated, are progressing or have been concluded in the cosmetics sector. In this presentation, the Commission services have outlined in a short, yet comprehensive way, all activities within the cosmetics sector related to three main topics: (i) Substances with endocrine disrupting properties, (ii) nanomaterials and (iii) the “Chemicals Strategy for Sustainability” as part of the Commission’s Green Deal. For each of these topics, an overview of the Commission activities is presented, together with follow-up proposals and future actions.

– Overview of the compliance process – what does it imply?

– Why it is crucial to be first compliant?

– RAPEX

– SUE / UE

– keeping your PIF, including SA report, updated periodically

To be compliant on the process before sales need a couple of measures that to be anticipated. First, to be compliant it means to contribute to consumer safety and to the protection of their health. The good understanding of the respective roles and responsibilities of each person involved on the sales chain ensures compliance with the Cosmetics Regulation. The setting of an information system: PIF (product information file) and safety assessment report are the required steps, not only before to place on the market but also during all the time market. This follow-up establishes an organized system for the exchange of information concerning products that may affect the health and the safety of consumers by means RAPEX : Rapid Alert System for dangerous non-food products is the EU rapid alert system notifying member states about risks to the health and safety of consumers.

– Overview of 22716 requirements

– Highlights on how important is to be GMP certified

The Cosmetics Regulation (EC) 1223/2009 requires that all cosmetic products placed on the European market comply with Good Manufacturing Practices (GMP) set by the ISO 22716 standard. This standard covers the quality aspects of the product. It gives guidelines for the production, control, storage and shipment of cosmetic products. GMP concern all those involved in the manufacture, such as: raw materials providers, finished product manufacturers, distributors, importers / exporters. It’s important to note that ISO 22716 does not cover aspects of protection of the environment. This presentation presents the goal of GMP for cosmetic products (e.g. : prevent contamination, prevent mix ups and errors, establish process controls,…) and how set up a couple of measures that have to be implemented in relation to the manufacturing process, control, storage and shipment. Also, the following questions: how GMP affect product processing and how make audit of the quality systems ? are discussed.

– type of cosmetic cases reaching the court

– What happens then and there?

– how is the court interpreting the cosmetics regulation 1223/2009/EC

As any industrial product, cosmetic products are sometimes subject to legal expertise, always with the objectives to assure the protection of the consumer and to protect their health. Expertise cases are subject of various investigations lead by judicial experts and under the direction of an investigating judge. Identification of counterfeits, search for unauthorized substances, investigation of non – compliant labeling, misleading product, are all cases that can be submitted to expertise…

The Medical Device and In-Vitro Diagnostic legislations underwent the biggest change in the history with the publication of the two regulations 2017/745 and 2017/746 in May 2017. Since the publication of those regulations the various stakeholders are trying to understand the new requirements and to identify the Gaps to be closed in order to ensure continuous compliance and product availability on the EU market after date of applications of both regulations. Various guidance documents and FAQ publications were published, but the number of remaining open questions is still high. During this presentation the challenges of the new requirements of the MDR and IVDR will be presented by explaining the key changes to the QMS Obligations. A summary of the QMS obligations to be fulfilled before date of application of both regulations will be also given.

The IVD industry is being faced with a significant challenge. The path to compliance to the IVD-R is scattered with obstacles ranging from the lack of clear guideline documents, still too few available Notified Bodies, lack of EU Reference Labs, etc. With only few months left to prepare and send to the Notified Body their submissions, IVD manufacturers must do it right first time in order to avoid the potential discontinuation of their devices on the EU market. This presentation will address the most sensitive of these obstacles with some practical hints on how to overcome them.

Traditionally, custom-made medical devices have benefitted from a reduced regulatory burden under Directive 93/42/EEC, with a general understanding that they are necessarily low-volume or once-off productions. However, advancing computer-driven technologies (such as CAM milling, additive production methods and 3D printing) have enabled production of devices that can be personalized to a patient’s specific anatomy. These advances have blurred the lines separating “series-produced” devices based on validated designs and “true” custom-made devices where device design specifications are (at least in part) established by an authorised prescribing professional. The Medical Device Regulation 2017/745 establishes a revised definition of “custom-made device” that excludes devices which are mass-produced by means of industrial manufacturing processes. In parallel, the Internal Medical Device Regulators Forum (IMDRF) has published a guidance document establishing that “patient-adapted” or “patient-specific” devices cannot be considered to be custom-made devices. These shifts in technology and in regulatory criteria may change the status quo for many devices which, to-date, have been considered to be custom-made. In this presentation, we shall explore the new MDR definition as well as the related IMDRF concepts so that manufacturers can determine if their personalized devices still fit the new MDR definition of “custom-made device”. If not, they will need to reconsider the conformity evaluation procedure of these devices as regular, series-produced devices bearing the CE marking.

Following the end of the transition period with the EU, the UK has introduced some regulatory changes for how devices will be placed on the UK market. This presentation will cover what those key changes will be, as well as the future opportunities for device regulation in the UK.