The cosmetics legislation in force in Poland are included in two main legal acts. The regulation at the EU level, that applies directly in the Polish law is Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November, 2009. The aim of the mentioned Cosmetics Regulation 1223/2009/EC is to ensure human safety and health in connection with the use of cosmetic products. The annexes to Regulation 1223/2009/EC include, among others: list of substances prohibited for use in cosmetic products (Annex II) and lists of substances permitted for use with restrictions (Annexes III – VI). This document regulates in details: the issues related to the composition of a cosmetic product, labeling, manufacturing, documentation and the product safety. Each year, several regulations amending the annexes to Regulation 1223/2009/EC are published. The national polish regulation is the Act of 30 March, 2001 on cosmetics, which specifies requirements regarding the composition, labeling of cosmetics and the conditions for the cosmetics trade.
The main reason such frequent legislative changes is the rapid scientific and technological development. This is why we are in continuous process of legislative changes. The early monitoring and responding to regulatory changes can bring immediate benefits. I mean the benefits for cosmetics producers, but also for the laboratories testing cosmetics and the specialists assessing their safety – Safety Assessors. The changes in legal regulations regarding ingredients are the result of developments in scientific knowledge in the field of toxicology, risk assessment and technological development. We know more and more about the effects of chemical substances in the contact with the human body, and all risks to human health (and the environment) must be efficiently eliminated or reduced to a minimum.
The scientific body, that assesses the safety of cosmetic ingredients, for which new scientific data appears, is the Scientific Committee on Consumer Safety (SCCS). The published legal acts amend the annexes of Regulation 1223/2009/EC. The opinions of the SCCS Committee and any other available information about cosmetics ingredients should be taken into account by the specialists assessing product safety and the cosmetics manufacturers.
The cosmetic ingredients are also regulated by chemical regulations – Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (CLP).
Regulation 1272/2008/EC (CLP) sets out the criteria for the classification of chemical substances. The classification of a substance according to CLP may result in a ban or restriction on the cosmetic ingredient use. A special legal regime applies to substances classified as CMR, i.e. substances that are carcinogenic, mutagenic and toxic to reproduction. The REACH regulation refers to the management of chemical substances and mixtures and does not apply to finished products provided to the consumer, which means that the REACH requirements do not apply directly to the finished cosmetic products, but apply to the substances – the ingredients of the cosmetic products. The cosmetics manufacturers’ REACH obligations include the safe use of chemical substances and mixtures (cosmetic ingredients) according to the information in safety data sheets (SDS, MSDS) and exposure scenarios. Although as, I mentioned, the REACH requirements do not directly apply to finished cosmetic products, the REACH regulations, like the CLP regulations, may introduce restrictions or bans on the use of a concrete ingredient, often directly referring to its use in the cosmetic.
The changing cosmetic legislation certainly, it is not a comfortable element for cosmetics manufacturers mainly in terms of cost. The early regulatory changes monitoring and responding can bring direct benefits, including reducing business risk, minimizing future reformulation costs and losses, and ultimately avoiding non-compliant product recalls. So frequent changes in regulations for cosmetic ingredients require responsible planning of decision-making processes in the company. I also think it is necessary to understand the legislative processes, to analyze the approximate time frames, to be well prepared for the upcoming changes. Certainly, companies are helped in this by associating in cosmetics manufacturers associations, which offer their members some tools to monitor changing legislation.
The stages of the regulatory process in the area of cosmetics in EU can be presented as follows:
- after the scientific report about the possible harmful effects of an ingredient, the discussion stage in the European Commission begins (mainly at the level of the Working Group on Cosmetics)
- Commission submits a «mandate» – a kind of «order» – to the SCCS Committee with a request to assess the safety of the used ingredient, and here the SCCS usually has about 9 months to issue such a preliminary opinion and its publication,
- one more time for consultations, which usually last about another two months,
- publication of the final opinion (this also usually takes about two months),
- presentation of a draft regulation basing on the SCCS final opinion in the European Commission (another two months),
- stage of consultations of the project in the Commission – internal voting (about 10 months),
- publication of the regulation in the Official Journal of the European Union.
From the moment of act publication in the Official Journal, the transitional periods for placing non-compliant products on the market and making available on the market begin – in total about 2 years until the publication of the regulation, plus any others determined additional transitional periods.
The last stage is the new regulations entry into force. From this moment, all ingredient use prohibitions come into force – a placing on the market ban and presence on the market, after which the manufacturer and other entities in the supply chain have a few months to withdraw from the market legally placed products. It is worth to mention, that it does not necessarily have to be a withdrawal of products from the market, it can be solved by using a sales mechanism, such as selling products off, offering attractive discounts, adding the product as a free gift to others, etc. In my opinion, it is not a good idea to adapt cosmetic products at the stage of already published regulation. It is usually too late for the company to prepare for the changes.
So the conclusion is that the sooner we know everything about the upcoming consultations, whether at the stage of drafting opinions in the SCCS or at the stage of ongoing consultations in the European Commission, the sooner we are able to prepare for the changes.
Such option – constantly informing producers about the legislative changes at their very early stages – is provided by organizations associating cosmetics manufacturers as well as safety assessors who prepare the safety assessment reports, who are in constant contact with the customer.
It was about the changing cosmetic legislation in the European Union, and what is going on in the world, in the area of cosmetics regulations? Let’s take a brief look at the legislative changes in the US market.
The US market is an extremely attractive area for European cosmetics producers. That is why an increasing number of European manufacturers are trying to promote their products on the US market.
The legal body that regulates cosmetic products in the US is the Food and Drug Administration (FDA). To sell cosmetics in the US, you need to consider the federal cosmetics regulation that apply to all US States.
The two main federal law acts applicable to cosmetic products in the USA are:
- Federal Food, Drug and Cosmetic Act (FD&C Act),
- Fair Packaging and Labelling Act (FPLA).
And also many other state provisions, which also have to be taken into account.
On 29 December 2022, the US President signed into law the Consolidated Appropriations Act 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a long-awaited reform of the US cosmetics regulation. MoCRA is the biggest amendment of the Food, Drug and Cosmetics Act since 1938. This new legislation will affect all cosmetic companies that manufacture and distribute cosmetics in the USA.
With MoCRA the main changes are taking place in the following areas:
- the facility registration (Cosmetic Direct portal, U.S. Agent function for facilities located outside the USA),
- product listings (every year updated),
- label and ingredient review (Responsible Person’s data, the allergens labelling – FDA will prepare the guidelines (deadline – June 2024),
- Adverse Event Reporting,
- Good Manufacturing Practice (GMP) – we are also waiting for FDA guidelines (deadline – December 2025),
- changes in the area of confirming the safety of cosmetics products – safety substantiation.
In the light of increasing ecological awareness and the need using of safe products, the changing cosmetic regulations is becoming an indispensable element of the cosmetics market. It is a dynamic process that will require constant monitoring and adaptation to the new challenges.
It is important that the cosmetics industry, together with the regulators and the consumers, should be ready on time to change and apply the new standards in the future.
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