{"id":7603,"date":"2018-01-05T08:00:18","date_gmt":"2018-01-05T14:00:18","guid":{"rendered":"https:\/\/www.ulprospector.com\/knowledge\/?p=7603"},"modified":"2018-01-12T12:48:51","modified_gmt":"2018-01-12T18:48:51","slug":"pcc-eu-cosmetic-claims-updated-free-from-claims","status":"publish","type":"post","link":"https:\/\/ulprospector.ul.com\/7603\/pcc-eu-cosmetic-claims-updated-free-from-claims\/","title":{"rendered":"EU Cosmetic Claims: Updated Guidelines on “Free From” Claims"},"content":{"rendered":"
\"EU
Copyright: zerbor\/123RF Stock Photo<\/a><\/figcaption><\/figure>\n

As required by the EU Cosmetics Regulation (EC No 1223\/2009, Article 20), the acceptability of a claim made on a cosmetic product is determined by its compliance with the common criteria. Established by the EU Commission and the EU Member States, these six common criteria (namely Legal compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed decision-making) are reported in Regulation EU No 655\/2013.1<\/sup><\/p>\n

The EU Commission and the EU Member States published a revised version of the guidelines for the application of the common criteria.2<\/sup> This new version contains two additional annexes, one on \u2018free from\u2019 claims (annex III) and one on the \u2018hypoallergenic\u2019 claim (annex IV)<\/strong>. In summary, these new annexes introduce the following changes in the management of cosmetic claims:<\/p>\n

Annex III: \u2018Free from\u2019 claims<\/h3>\n\n\n\n\n\n\n\n\n\n\n
Type of \u2018Free from\u2019 claim\u00a0<\/strong><\/td>\nStatus\u00a0<\/strong><\/td>\nReasoning\u00a0<\/strong><\/td>\n<\/tr>\n
\u2018Free from\u2019 + ingredient prohibited by the EU Cosmetics Regulation<\/td>\n\n
\u2297<\/h5>\n<\/td>\n
E.g. \u2018Heavy metals free\u2019\u00a0<\/em><\/strong><\/p>\n

Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed.\u00a0<\/em><\/td>\n<\/tr>\n

\u2018Free from\u2019 + ingredient or ingredients category that are present in the product<\/td>\n\n
\u2297<\/h5>\n<\/td>\n
E.g. \u2018Free from formaldehyde\u2019 (if the product contains formaldehyde releasers)\u00a0<\/em><\/strong><\/p>\n

If it is claimed on the product that it [does not] contain[s] a specific ingredient, the ingredient shall be deliberately [absent] present.\u00a0<\/em><\/td>\n<\/tr>\n

\u2018Free from\u2019 + ingredient not supposed to be present in the product<\/td>\n\n
\u2297<\/h5>\n<\/td>\n
E.g. \u2018Preservative free\u2019 (if the product is a fine fragrance containing high amounts of alcohol or bath salts, not expected to contain preservatives)\u00a0<\/em><\/strong><\/p>\n

Claims shall not attribute to the product concerned specific characteristics if similar products possess the same characteristics.<\/em><\/td>\n<\/tr>\n

\u2018Free from allergenic \/ sensitizing substances\u2019<\/td>\n\n
\u2297<\/h5>\n<\/td>\n
A complete absence of the risk of an allergic reaction cannot be guaranteed and the product should not give the impression that it does.\u00a0<\/em><\/strong><\/p>\n

“Free from” claims or claims with similar meaning should not be allowed when they imply guaranteed properties of the product, based on the absence of (an) ingredient(s), which cannot be given.\u00a0<\/em><\/td>\n<\/tr>\n

\u2018Free from\u2019 + ingredients category (e.g. fragrance, preservative, colorant)<\/td>\n\n
OK\/<\/h5>\n
\u2297<\/h5>\n<\/td>\n
E.g. \u2018Preservative free\u2019 is wrong if the product contains an ingredient, not in the official list of preservatives (Annex V) but having antimicrobial properties.\u00a0<\/em><\/strong><\/p>\n

E.g. \u2018Fragrance free\u2019 is wrong if the product contains an ingredient that exerts a perfuming function, regardless of its other possible functions in the product.\u00a0<\/em><\/strong><\/p>\n

This claim is acceptable except if the product contains an ingredient having properties of this ingredients family as a side function.\u00a0<\/u><\/em><\/td>\n<\/tr>\n

\u2018Free from\u2019 + an ingredient or an ingredients family that are legally used<\/td>\n\n
\u2297<\/h5>\n<\/td>\n
E.g. \u2018Parabens free\u2019\u00a0<\/em><\/strong><\/p>\n

Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used.\u00a0<\/em><\/td>\n<\/tr>\n

\u2018Free from\u2019 claims that allow an informed choice to a specific target group or groups of end users<\/td>\n\n
OK<\/h5>\n<\/td>\n
E.g. \u2018Free from alcohol\u2019 in a mouthwash intended as a family product.\u00a0<\/em><\/strong><\/p>\n

E.g. \u2018Free from animal-derived ingredients\u2019 in Vegan products.\u00a0<\/em><\/strong><\/p>\n

Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice.\u00a0<\/em><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Annex IV: \u2018Hypoallergenic\u2019 claim<\/h3>\n

The claim “hypoallergenic” can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential. Evidence to support the claim must be available by verifying and confirming a very low allergenic potential of the product through scientifically robust and statistically reliable data (for example reviewing post-marketing surveillance data, etc.).<\/p>\n

A product claiming to be \u2018hypoallergenic\u2019 will not contain known allergens or allergens precursors.<\/p>\n

By making reference to the SCCS Memorandum SCCS\/1567\/15,3<\/sup> these guidelines make useful clarifications about tests performed in healthy human volunteers such as the Human Repeated Insult Patch Tests (HRIPT). This version of the guidelines is less stringent than its initial draft and brings clarifications: hazard assessment of ingredients via HRIPTs is unethical and should be strictly prohibited. However, tolerance studies of a cosmetic product in humans are acceptable. Ideally, the\u00a0use of Repeated Open Application Tests (ROAT) should be preferred to HRIPTs conducted on a finished cosmetic product.<\/p>\n

The legal status of these guidelines was rather unclear and a legal review has been performed by Ms. Sylvie Gallage of Hogan Lovells LLP, a lawyer and specialist of this topic.<\/p>\n