{"id":3699,"date":"2026-10-23T12:20:04","date_gmt":"2026-10-23T10:20:04","guid":{"rendered":"https:\/\/www.bayoocare.com\/unkategorisiert\/cosmetics-regulation-2026-909-what-will-change-for-your-formulations-starting-january-1-2027\/"},"modified":"2026-10-23T12:27:37","modified_gmt":"2026-10-23T10:27:37","slug":"cosmetics-regulation-2026-909-what-will-change-for-your-formulations-starting-january-1-2027","status":"publish","type":"post","link":"https:\/\/www.bayoocare.com\/en\/regulatory-newsletter\/cosmetics-regulation-2026-909-what-will-change-for-your-formulations-starting-january-1-2027\/","title":{"rendered":"Cosmetics Regulation 2026\/909: What Will Change for Your Formulations Starting January 1, 2027"},"content":{"rendered":"

What does Regulation (EU) 2026\/909 cover?<\/h2><\/h2><\/div>

The Commission adopted the regulation on April 27, 2026, and it amends Regulation (EC) No. 1223\/2009, i.e., the EU Cosmetics Regulation. The changes affect entries in Annexes II (prohibited substances), III (restricted substances), V (preservatives), and VI (UV filters). The text was published in the Official Journal on April 28, 2026, and according to SGS<\/a>, it entered into force on May 18, 2026. However, most substances are subject to their own transition periods, which are listed below.<\/p>\n<\/div>

Which substances will be affected starting in 2027?<\/h2><\/h2><\/div>

Benzyl salicylate and citral have the widest-reaching impact because both fragrances are found in perfumes, creams, deodorants, and many other products. In the future, maximum concentrations will apply to both, based on the product category. In addition, there are aluminum compounds with product-specific maximum limits, as well as a ban on triphenyl phosphate, which many people recognize from nail polish.<\/p>\n<\/div>\n

\n\n\n\n\n\n\n\n\n\n\n\n
Content<\/th>\nWhat’s Changing<\/th>\nSample values from the appendix<\/th>\n<\/tr>\n<\/thead>\n
Benzyl Salicylate (Appendix III, No. 75)<\/td>\nMaximum concentrations per product category<\/td>\n0.5% in other skin and hair care products (excluding sprays), 0.7% in body lotion, 0.2% in facial makeup, 4% in fragrances<\/td>\n<\/tr>\n
Citral (Annex III, No. 70)<\/td>\nMaximum concentrations per product category; labeling required at 0.001% (leave-on products) or 0.01% (rinse-off products)<\/td>\n0.15% in other leave-on skin care products, 0.6% in fragrances, 0.032% in deodorants<\/td>\n<\/tr>\n
Aluminum compounds (Annex III, new, No. 379)<\/td>\nProduct-specific maximum levels, calculated as aluminum<\/td>\n7.73% in non-aerosol deodorants, 3.24% in aerosol deodorants, 3.18% in toothpaste<\/td>\n<\/tr>\n
Triphenyl phosphate (Annex II)<\/td>\nProhibited<\/td>\nNo limit value; the substance must not be present<\/td>\n<\/tr>\n
Water-soluble zinc salts (Annex III, No. 24)<\/td>\nAdjusted maximum levels, calculated as zinc<\/td>\n1% in toothpaste for users over one year of age, 0.1% in mouthwashes<\/td>\n<\/tr>\n
Acetylated vetiver oil (Annex III, new, No. 380)<\/td>\nMaximum levels per category; raw material stabilized with 1% alpha-tocopherol<\/td>\n0.9% in fragrances, 0.05% in deodorants and makeup<\/td>\n<\/tr>\n
DHHB (Annex VI, No. 28)<\/td>\nUV filter remains permitted; impurity limited<\/td>\nNo more than 10%; di-n-hexyl phthalate no more than 10 ppm<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

Overview of Annex III of the Cosmetics Regulation:<\/b> Nine of the twelve substances are listed in Annex III, the list of restricted substances, namely zinc salts, citral, benzyl salicylate, aluminum compounds, acetylated vetiver oil, and four hair dyes. Triphenyl phosphate is listed in Annex II (Prohibited Substances), silver-zinc zeolite in Annexes II and V, and DHHB in Annex VI (UV Filters).<\/p>\n

When it comes to citral, it\u2019s worth taking a closer look at the raw materials, as the substance occurs naturally in essential oils such as lemongrass. According to MDSS Cosmetics<\/a>, citral from natural sources is therefore also included in the total content, meaning that even formulations without added fragrance may be affected. In addition, four hair colorants are being added to Annex III, and silver-zinc zeolite is being moved from the list of prohibited substances to the list of permitted preservatives. According to the SGS and the recitals, the regulation does not provide for a transition period for these two groups; they are therefore already in effect.<\/p>\n

A note about the search: Triphenyl phosphate is not the same as TPO, the photoinitiator found in gel polishes that often comes up in reports about nail products.<\/p>\n<\/div>

<\/span><\/div>

What are the deadlines?<\/h2><\/h2><\/div>\n
\n\n\n\n\n\n\n\n
Effective Date<\/th>\nWhat Applies<\/th>\n<\/tr>\n<\/thead>\n
January 1, 2027<\/td>\nProducts containing triphenyl phosphate, citral, benzyl salicylate, aluminum compounds, zinc salts, acetylated vetiver oil, or DHHB may only be placed on the market if they comply with the new requirements<\/td>\n<\/tr>\n
July 1, 2028<\/td>\nNon-compliant products may also no longer be made available on the market<\/td>\n<\/tr>\n
August 1, 2028<\/td>\nThis later date applies to the citral isomers (E)- and (Z)-3,7-dimethylocta-2,6-dienal, i.e., geranial and neral<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

\u201cPlacing on the market\u201d refers to the initial making available of a product on the EU market, whereas \u201cmaking available\u201d refers to any subsequent transfer within the supply chain up to the end consumers. Products that were already placed on the market before January 1, 2027, may therefore continue to be sold until mid-2028. New batches, however, must comply with the new limits starting at the beginning of the year.<\/p>\n

The timeframe through 2028 seems generous, but in practice it is tighter than it appears, because the deadline for placing the product on the market begins in just over two months. By then, a modified formulation must be developed, safety-assessed, and approved with an updated label\u2014and each of these steps requires lead time.<\/p>\n<\/div>

<\/span><\/div>

What does this mean for the formulation, CPSR, and label?<\/h2><\/h2><\/div>

The first step is classification: For each product, it must be determined which category it falls into, because the permissible level depends on that. For example, a body lotion may contain more benzyl salicylate than any other skin care product, and when it comes to aluminum, the limits differ significantly between deodorants, toothpaste, and makeup. If a formulation exceeds the limit, it must be reformulated, which typically requires a new Cosmetic Product Safety Report (CPSR). This report is part of the Product Information File (PIF) maintained by the responsible person. We explain the difference between the CPSR and the PIF on our page on Compliance for Cosmetic Products<\/a>.<\/p>\n

The label is also worth a look. Citral and benzyl salicylate must be listed in the ingredients list if their concentrations exceed the specified thresholds, and for aluminum, the appendix requires warning labels\u2014for example, on talcum powder, which should be kept away from children\u2019s noses and mouths. Retailers carrying multiple variants of a product should also clarify which ones differ in their ingredient composition, as each must then be evaluated individually.<\/p>\n<\/div>

Conclusion<\/h2><\/h2><\/div>
January 1, 2027, is just around the corner, and anyone who reviews their portfolio now against the revised annexes will be able to identify early on which products need to be adjusted and where the existing documentation remains valid. The transition period through 2028 is particularly helpful for selling off existing inventory rather than for new batches.<\/section>\n<\/div>

Here’s how BAYOOCARE can help you<\/h2><\/h2><\/div>

BAYOOCARE reviews your product portfolio against the revised annexes, assesses where formulations need to be adjusted, and updates your documentation\u2014including the CPSR\u2014to ensure your cosmetic products remain compliant even after the deadlines have passed. Please feel free to contact us; we\u2019ll work with you to create a schedule that fits your batches and approvals.<\/p>\n<\/div>

FAQ: Frequently Asked Questions About Cosmetics Regulation 2026\/909<\/h3><\/h2><\/div>

<\/i><\/i><\/span>What does Regulation (EU) 2026\/909 cover?<\/span><\/a><\/h4><\/div>
\n

It amends the EU Cosmetics Regulation (EC) No. 1223\/2009 with regard to twelve substances, including benzyl salicylate, citral, aluminum compounds, and triphenyl phosphate, and establishes bans, maximum concentrations, or new conditions.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>When do the new regulations for cosmetic products take effect?<\/span><\/a><\/h4><\/div>
\n

For most of the substances covered, noncompliant products may no longer be placed on the market as of January 1, 2027.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>Which substances are affected?<\/span><\/a><\/h4><\/div>
\n

The substances affected are benzyl salicylate, citral, aluminum compounds, triphenyl phosphate, water-soluble zinc salts, acetylated vetiver oil, and DHHB, as well as four hair dyes and silver-zinc zeolite, for which the entries have been updated.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>Until when can existing products still be sold?<\/span><\/a><\/h4><\/div>
\n

Products placed on the market before January 1, 2027, may be made available until July 1, 2028; for the citral isomers geranial and neral, until August 1, 2028.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>Do I need to create a new CPSR after a reformulation?<\/span><\/a><\/h4><\/div>
\n

Generally speaking, yes, because the safety assessment must reflect the changed composition. Whether a new report or an update is sufficient depends on the specific case and should be clarified with the safety assessors.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>What are the potential consequences of violations?<\/span><\/a><\/h4><\/div>
\n

National authorities are responsible for enforcement, and depending on the Member State, measures may include sales bans, recalls, and fines, among others. For more information, see the FAQs on our Cosmetics Compliance page.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>Does the EU Cosmetics Regulation apply directly in Germany?<\/span><\/a><\/h4><\/div>
\n

Yes, Regulation (EC) No. 1223\/2009 has been directly applicable in all Member States since July 11, 2013, and the same applies to the amendment introduced by Regulation 2026\/909. The National Cosmetics Regulation of July 16, 2014, and the Food and Feed Code (LFGB) supplement these provisions, particularly regarding the indication of the place of manufacture, the requirement for certain information to be provided in German, and the penalties, while the rules on ingredients originate from the EU. The Munich Chamber of Industry and Commerce (IHK M\u00fcnchen) provides an overview in its fact sheet on cosmetics law<\/a>.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>Is benzyl salicylate harmful?<\/span><\/a><\/h4><\/div>
\n

The Scientific Committee on Consumer Safety (SCCS) considered the substance safe up to the maximum concentrations specified by the industry. Nevertheless, the Commission sees a potential risk if these levels are exceeded and therefore limits its use to the levels specified in Annex III. This decision was prompted by potential endocrine-disrupting properties, for which the 2023 SCCS opinion reportedly<\/a> found no evidence of effects. This is a regulatory classification and does not constitute a statement regarding individual products.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>What is citral, and why is its use being restricted?<\/span><\/a><\/h4><\/div>
\n

Citral is a fragrance that was previously regulated as an allergen with labeling thresholds. On July 29, 2024, the SCCS assessed its sensitization potential and deemed the concentrations proposed by the industry to be safe, and the Commission is now limiting its use to these maximum levels.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>Why is triphenyl phosphate being banned?<\/span><\/a><\/h4><\/div>
\n

On July 25, 2024, the SCCS was unable to draw a safety conclusion because the data were insufficient for a complete assessment and potential genotoxicity could not be ruled out. Due to the potential health risk, the substance was included in Annex II.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>What are the limits for aluminum in cosmetics?<\/span><\/a><\/h4><\/div>
\n

The maximum levels are product-specific and calculated as aluminum; for example, 7.73% in non-aerosol deodorants, 3.24% in aerosol deodorants, and 3.18% in toothpaste. The appendix distinguishes between various categories, ranging from deodorants to makeup to talcum powder.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

Sources:<\/b> Annex to Regulation (EU) 2026\/909 (Council document)<\/a>, SGS<\/a>, CIRS<\/a>, MDSS Cosmetics<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>

Contact Us<\/h3><\/div>

Are you developing AI-based medical devices and looking for an experienced designated manufacturer to guide you through risk management, conformity assessment, and the new deadlines under the AI Regulation? Contact us for a no-obligation consultation.<\/p>\n<\/div>

How to Contact Us<\/span><\/a><\/div><\/div><\/div>
<\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"

Have you already checked your formulations against the new limits? With Regulation (EU) 2026\/909, the European Commission has amended the EU Cosmetics Regulation for twelve substances, and as of January 1, 2027, only products that meet the new requirements may be placed on the market. This article explains which substances are affected, what deadlines apply, and what steps manufacturers and distributors should take now.<\/p>\n","protected":false},"author":50,"featured_media":3650,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[247],"tags":[49,187,43,283,288],"class_list":["post-3699","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-newsletter","tag-eu","tag-healthcare","tag-medical-devices","tag-quality-management","tag-regulation"],"yoast_head":"\nCosmetics Regulation 2026\/909: What Will Change for Your Formulations Starting January 1, 2027 – BAYOOCARE<\/title>\n<meta name=\"description\" content=\"Regulation (EU) 2026\/909: Which 12 substances the Cosmetics Regulation will change starting in 2027, what deadlines apply, and what manufacturers should review now.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bayoocare.com\/en\/regulatory-newsletter\/cosmetics-regulation-2026-909-what-will-change-for-your-formulations-starting-january-1-2027\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cosmetics Regulation 2026\/909: What Will Change for Your Formulations Starting January 1, 2027 – BAYOOCARE\" \/>\n<meta property=\"og:description\" content=\"Have you already checked your formulations against the new limits? 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