The new measures incorporate the latest technical decisions adopted within Mercosur, continuing the harmonisation of cosmetic regulations across the region. Companies placing products on the Brazilian market should review formulations and compliance strategies, as several ingredients have changed regulatory status and transition periods are now in force.
Regulatory Framework
Brazil regulates cosmetic ingredients through two complementary lists:
- Prohibited substances, which cannot be used in cosmetic products.
- Restricted substances, which are allowed only under defined conditions, such as concentration limits, product type or specific warnings.
These lists are essential references for cosmetic product registration and notification in Brazil. As a Mercosur member, the country periodically updates its national legislation to reflect regional technical regulations. The latest revisions implement Mercosur Resolutions GMC No. 06/25 and GMC No. 07/25, bringing Brazil’s framework closer to international regulatory trends, particularly those based on the classification of substances with carcinogenic, mutagenic or reproductive toxicity (CMR) concerns.
Changes to the prohibited substances list
RDC No. 1030/2026 updates the annex of the previous prohibited substances regulation (RDC No. 529/2021). The revision includes newly banned ingredients, amendments to existing entries and the removal of several substances that will now be regulated under restricted conditions instead.
– New prohibited ingredients
Among the most relevant additions are:
- Boric acid, diboron trioxide and a broad range of borates and boron derivatives.
- Sodium perborate compounds.
- Polyurethane-18 and Polyurethane-19.
- Dibutyltin hydrogen borate.
- Nickel bis(tetrafluoroborate).
- Technical diaminotoluene.
- Ketoconazole.
- Dichloromethane (methylene chloride).
- Butylphenyl Methylpropanal (Lilial).
- Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Lyral).
Many of these ingredients have already been subject to restrictions or prohibitions in other jurisdictions, reflecting a broader international trend towards tighter control of substances associated with safety concerns.
– Existing entries revised
The regulation also updates several existing prohibited entries, including:
- 4-Benzyloxyphenol and 4-Ethoxyphenol.
- Mercury and its compounds.
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO).
- N,N-Dimethyl-p-toluidine.
These amendments mainly clarify the scope of the prohibition and improve consistency with the latest Mercosur text.
– Four ingredients move from prohibited to restricted
One of the most notable aspects of the revision is that four substances have been removed from the prohibited list and transferred to the restricted substances list. This means they are no longer completely banned but may only be used under the conditions established in the new regulation.
The affected ingredients are:
- Benzoyl peroxide.
- Methyl eugenol.
- Hydroquinone.
- Azelaic acid.
Manufacturers using these ingredients should not assume they are now freely permitted. Their use remains subject to specific concentration limits and application conditions defined in the official annex of RDC No. 1029/2026.
Transition periods
ANVISA has established implementation periods to allow companies time to adapt existing products.
For changes affecting the prohibited substances list, most products already authorised or notified in Brazil must comply within 12 months from publication of the regulation.
Products containing Lilial (Butylphenyl Methylpropanal) or Lyral (Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde) benefit from a longer 18-month transition period.
For the new restricted substances list, manufacturers have 24 months to comply with the updated requirements.
A continuing trend towards international harmonisation
These revisions are part of a broader effort to align cosmetic legislation across Mercosur member states. Similar regulatory updates have recently been introduced in neighbouring countries, reinforcing a common regional approach to ingredient safety.
For companies marketing cosmetics across Latin America, this increasing harmonisation may simplify long-term regulatory planning, but it also highlights the importance of continuously monitoring legislative developments throughout the region.
