It’s important to know these rules not only to be able to legally enter the market, but also to build trust with customers and protect your brand. Certified Cosmetics helps brands through this process with great care, from safety checks to product information files (PIFs) and notifications. Below, you’ll find a full list of regulatory requirements along with steps you can take to make sure you follow them.
Understanding the Regulatory Framework in Malta
EU Regulation and National Application
Malta implements Malta cosmetic regulations by adopting the EU Cosmetics Regulation (EC) No. 1223/2009, which harmonizes cosmetic safety rules across all EU Member States. This rule says that cosmetic products must meet certain safety tests, labeling rules, and notification requirements.
The Malta Medicines Authority is in charge of medicines, but the Malta Competition and Consumer Affairs Authority (MCCAA) is in charge of making sure that cosmetics rules are followed in Malta. No matter what the authority structure is, all cosmetic products sold in Malta must follow EU rules.
Some important parts of these rules are making sure that the product is safe, that it is labeled correctly, and that it doesn’t make any medical claims. These rules are meant to keep people healthy and make sure that there is fair competition in the internal market.
Who Is Responsible for Compliance?
Every brand in Malta must have a Responsible Person (RP) based in the EU in order to fully comply with cosmetic compliance Malta. The RP is in charge of making sure that EU law is followed, which includes making and keeping the necessary documents, like the PIF Malta.
The Responsible Person has to:
- Make sure that products are safe and meet all rules.
- Keep all documents that show you are following the rules.
- Be the official point of contact for authorities if they need to ask questions or check things out.
These duties are very important for entering the market and following the law in all EU countries, including Malta.
Cosmetic Product Safety Report
The Cosmetic Product Safety Report (CPSR) is an important part of cosmetic compliance in Malta. It gives a structured scientific evaluation of whether a cosmetic product is safe for its intended use. The CPSR looks at the whole formulation, including the toxicological profile, concentration, and possible exposure levels of each ingredient. It also looks at how and where the product is used, like whether it is put on the skin, lips, or eyes, and whether it is a leave-on or rinse-off product. This makes sure that safety is tested not just in theory but also in real life when people use the product. A product cannot be legally sold in Malta or the rest of the EU without a valid CPSR.
A qualified safety assessor with a background in pharmacy, toxicology, or a related field must prepare and sign the CPSR. There should be a clear safety conclusion backed up by data, references, and reasonable assumptions, not just general statements. The report is also a key part of the PIF Malta and must be kept up to date whenever the formulation, ingredients, or rules change. The CPSR is the main document that the Responsible Person uses to show that the product meets all safety standards. A well-prepared CPSR for Malta greatly lowers the risk of breaking the law and helps companies follow the rules during inspections or market surveillance.
Product Information File (PIF Malta)
PIF Malta is a complete compliance file that organizes all of the safety, regulatory, and product information into one file. It is the official proof that a cosmetic product meets the rules for cosmetics in Malta and EU Regulation 1223/2009. The PIF has the CPSR for Malta, a detailed description of the product’s formulation and how it was made, and proof that the ingredients are safe. It also shows that the product label meets legal standards and that the claims made about the product are true and backed up. In practice, the PIF is the product’s “identity” in terms of regulation.
According to EU rules, the PIF must be easy for authorities to get to for at least ten years after the last batch of the product is sold. This means that it can’t be seen as a one-time administrative task; it has to be kept up to date and maintained throughout the product’s life. If the formulation changes, the supplier changes, or a new law affects an ingredient, the PIF must be updated to reflect these changes. Authorities may ask to see the PIF as proof of compliance during inspections or investigations into consumer safety. So, for both legal security and operational continuity, a full and well-kept PIF Malta is very important.
Notification and Labelling Requirements
Cosmetic Product Notification
The Cosmetic Product Notification Portal (CPNP) must be used to let people know about a cosmetic product before it can be sold in Malta. This centralized EU database makes sure that regulators in all EU countries can get important information about products. The notification has information like the type of product, the formulation type, the Responsible Person, and the countries where the product will be sold. This process makes the internal market more open and helps authorities respond better if there are safety issues or product recalls.
The notification includes:
- Product name and category.
- Identity of the Responsible Person.
- Member States where the product will be sold.
- Presence of substances of concern (e.g., certain nanomaterials or restricted ingredients).
Accurate and complete notifications streamline compliance and reduce market risks.
Labelling and Language Requirements
Labelling is a big part of Malta cosmetic regulations, and it has to follow EU rules for labelling. The required information includes the list of ingredients (in INCI format), the batch number, the nominal content, the product’s function, and any safety tips.
To be accepted in Malta, labels must be in English and/or Maltese. This makes sure that customers know exactly how to use the product safely. Proper labeling isn’t just a matter of following the rules; it’s also a sign of trust for customers and partners.
Practical Steps to Achieve Compliance
- Appoint a Responsible Person (RP) based in the EU. This is the first step in making sure that all regulatory obligations are met.
- Make a PIF Malta that follows the law. It should include CPSR for Malta, formulation, safety data, and proof of labeling.
- Before launching, send in a CPNP notification. Make sure all the data fields are correct so there are no delays or fines.
- Check the labeling and translate it. Make sure that all the necessary information is clear and in the right language(s).
- Regular audits are important because rules can change (for example, updates on banned ingredients).
Frequently Asked Questions (FAQ)
Q1. What authority regulates cosmetic products in Malta?
Cosmetic products sold in Malta are regulated under EU law, particularly Regulation (EC) No. 1223/2009. While the Malta Medicines Authority focuses mainly on medicines, MCCAA implements cosmetic regulations locally.
Q2. What is the purpose of CPSR for Malta?
A Cosmetic Product Safety Report (CPSR) assesses product safety scientifically and is required to show that the product is safe under normal use.
Q3. Why do products need a PIF Malta?
The PIF Malta holds all compliance documentation and must be made available to authorities upon request to prove conformity with regulations.
Q4. What languages are accepted for labelling?
Cosmetic labels must be in English and/or Maltese to ensure legal acceptance and clear communication to consumers.
Q5. Do products need CPNP notification?
Yes. Every cosmetic product must be notified through the Cosmetic Product Notification Portal before being placed on the market in Malta or anywhere in the EU.
Final Thoughts on Cosmetic Compliance in Malta
Achieving cosmetic compliance Malta is a structured process rooted in Malta cosmetic regulations that derive directly from EU law. By preparing a complete CPSR for Malta, maintaining a precise PIF Malta, and ensuring correct labelling and notification through CPNP, brands can confidently place products on the Maltese and EU markets. Certified Cosmetics stands ready to support every step of this journey with expert guidance and regulatory excellence.
Beyond legal compliance, following these regulatory steps also strengthens product quality, consumer trust, and long-term brand credibility. A transparent and well-documented compliance process reduces the risk of product withdrawals, fines, or reputational damage, especially in a highly regulated market like the EU. It also enables brands to scale more easily into other European countries, since the same regulatory framework applies across member states. In this way, compliance is not only a regulatory obligation but a strategic investment in sustainable market growth.
