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New EU Device Regulations

On April 5th, 2017 the EU formally approved the new Medical Devices Regulation, replacing the two existing directives – the Medical Devices Directive, and the Active Implantable Medical Devices Directive. The new regulation will come into effect after a 3-year transitionary period ending in Spring 2020.

The adoption of the new regulation across the EU is required to bring the existing 20 year old directives up to date with current and future advances in technology. The interpretation of the directives will also become more transparent and legally binding across all the member states and will no longer be left open to various legal interpretations. This will ensure a consistently high level of health and safety protection for the end user along with free and fair trade within the EU.

Rule 21

There are many consequences to the new regulation. Primarily, Rule 21 will affect manufacturers of various OTC products, cosmetics and household goods that contain active substances which come into contact with, are used on or are absorbed through the skin or other body orifices. Many of these products contain active substances with a medical claim i.e. Antiseptic, Hypoallergenic, Anti-ageing, etc. These products now face being reclassified at a higher medical device level based on those ingredients, and as such now require stricter clinical testing and proof of efficacy.

EU 655/2013 – Annex II & III

From 1st July 2019 an additional 2 annexes – Annex III & IV – due to a requirement laid out in EU Cosmetics Regulation 1223/2009, came into effect which will specifically affect Cosmetic products. EU Regulation (EC No. 655/2013) provides 6 common criteria that should be followed and each claim used on a products’ label needs to be substantiated.

These criteria are:

  • Legal Compliance
  • Truthfulness
  • Evidential Support
  • Honesty
  • Fairness
  • Informed Decision Making

Most cosmetic products on the market contain claims primarily used for marketing purposes, which going forward will be restricted and regulated.

Common claims used by cosmetic companies:

  • Characterisation of their function e.g. Anti-ageing
  • Efficacy statements e.g. Total Sunblock
  • Highlighting absence of substances e.g flavours, fragrances
  • Skin compatibility e.g Hypo-allergenic, sensitive
  • Addressing other health benefits other than the cosmetic purpose

Annex III – “Free-from” claims

“Free-from” claims are now heavily or completely restricted based on the legal aspects of the annex. The following are no longer acceptable:

  • Claims that convey a benefit where compliance with minimum legal requirements are already in action e.g Free from heavy metals
  • “Free-from” an ingredient or category already present in the product e.g. free from formaldehyde (if product contains formaldehyde releasers)
  • “Preservative-free” if a product contains a similar ingredient that has the same outcome e.g fine fragrance with high levels of alcohol or bath salts would not require preservatives in the first instance.
  • “Free-from allergenic/sensitizing substances. A complete absence of risk of an allergic reaction is not guaranteed and should not give the impression that it does.
  • “Parabens-free”. Claims should be subjective and should not denigrate competitors nor the ingredients that they legally use.

Annex IV – Hypoallergenic claims

“Hypoallergenic” claims may only be used in cases where the cosmetic product has been designed to specifically minimize its allergic potential. Manufacturers must now provide proof by verifying and confirming a very low allergenic potential through robust and reliable scientific data. A product claiming to be “Hypoallergenic” will contain no known allergens or allergen precursors.

*The legal status of these guidelines laid out in Annex III & IV are unclear and are continuously being reviewed by legal specialists. On one hand, it is assumed this is a working document with no legal status and therefore may not be deemed legally-binding. On the other these guidelines will be used by National Authorities and Courts of Justice to determine on case-by-case basis if a product complies with the EU Cosmetics Regulation No 655/2013 as and from 1st July 2019.


EU MDR 2013/745
EU Cosmetics Regulation EC 655/2013