Human Health & Safety
We are fully aware of risks associated with chemicals and have a professional approach to ensuring that a high level of human health protection comes first.
We help manufacturers to certify that products made available in any market around the world are safe for human health when used under normal or reasonably foreseeable conditions of use, including consideration of presentations, product labelling, instructions for use, product disposal and any other indications or information provided by manufacturers.
Cosmetic Product Safety Report (CPSR)
We provide customers with a product safety assessment report. Cosmetic Regulations require to provide specific information about any product before placing it on the market. The most important file is the Cosmetic Product Safety Report (CPSR). The safety assessor is the person responsible for producing such a document, in which it should be demonstrated that the product is safe. Only after obtaining positive conclusion in CPSR may the product be allowed to be placed on the market under condition it meets all applicable requirements. Basically, the CPSR must be easy to understand and well-argued; all requirements are described in Annex I to EC No 1223/2009. The cosmetic safety report is divided into 2 parts: A and B. All listed information listed under these titles in Annex I must be included in the CPSR, which is the required minimum.
Part A - Cosmetic product safety information includes:
Part A of the CPSR gathers all the required data on the cosmetic product to prove that the cosmetic product is safe. In this part the safety assessor identifies hazards and risks which the product may present to human health.
Part B - Cosmetic product safety assessment includes:
Part B of the CPSR is the summary of all the information presented in the part A. All the hazards are taken into account in the reasoning and conclusion.
Labels for cosmetic products
We check and validate the labels. Labelling of a cosmetic product in accordance with the requirements of correct labelling in Europe and in the world is to ensure the safety of the consumer's health when used under normal or reasonably foreseeable conditions of use, in particular: product presentations, labelling, instructions for use and disposal of the product and any other indications or information provided by the Responsible Person. We provide a label verification service for EU member states, Great Britain and countries outside Europe, such as Canada, the United States, Asian countries, and Middle East countries.
Requirements that must be met prior to marketing are described as follows. Cosmetic products must be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:
Where it is impossible for practical reasons to label the information about particular precautions to be observed in use and a list of ingredients, the information must be mentioned on an enclosed or attached leaflet, label, tape, tag or card.
In the case of small products where it is impossible for practical reasons for the information to appear on a label, tag, tape or card or in an enclosed leaflet, this information must appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.
The language of the information must be determined by the law of the Member States. The information mentioned in the ingredient list must be expressed by using the common ingredient name set out in the glossary provided in Article 33. In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature must be used.
Justification of claims and claims substantiation
We prepare documentation justifying the correctness of statements and declarations on the packaging. We produce hypoallergenic assessments and reviews of scientific literature in order to help in justifying claims. We also cooperate with accredited laboratories.
Warnings on the package
Use of the consumer products, such as cosmetics, biocides, detergents, toys and others, carries a type of risk. Before marketing the product, it is very important to assess the possible routes of exposure and the risk. Warnings are intended to indicate possible side effects of using the products incorrectly. Depending on the type of product and materials used, ingredients warnings should be directly matched to the individual product. According to warnings and instruction for use it is possible to predict and warn the consumer about the negative reactions. Our company ensures in reports and on packaging conditions of safe use and precautions for prevention of adverse reaction occurrence. The proper wording of the warning on the packaging is intended to inform the consumer about possible negative reactions in case of improper use of the product.
Product marketing in the various regions carries the obligation of specific labelling. The product must be appropriately described and labelled. In addition to the required different language versions, some regions have more requirements than others. It should be noted that, for example, cosmetic products in the EU require specific information that should be placed on the label. This information is not required in other regions, like US, Australia. Before marketing in the specific area, it is very important to check whether the product is labelled properly.
Indication of the appropriate warnings by the Safety Assessor is a part of safety assessment in which the possible negative reactions after product contact with skin, eyes, or after ingestion and inhalation are considered. For most products the risk is usually low. However, we always consider the worst-case scenario even if there is very low risk of misusing the product. Our experts carry out detailed analysis of the product ingredients, materials used and the finished product presentation. These are necessary elements, which enable consideration of possible exposure routes and the risks. In this way, both the consumer and the manufacturer are informed about possible adverse reactions which must be monitored.
Undesirable effects and serious undesirable effects
Post-marketing surveillance of cosmetics is often described as cosmetovigilance. Cosmetic safety surveillance is defined by the collection, evaluation and monitoring of spontaneous reports of adverse events observed during or after the normal or reasonably foreseeable use of a cosmetic product from customers. The assessment of these reactions is made by the Safety Assessor. Together with other tools, cosmetic safety oversight contributes to the post-market surveillance of a product. The person responsible for monitoring these advice activities is the person who places the product on the market and may be the importer, distributor, or manufacturer.
Notification of products
We submit products to the EU portal (CPNP) and the newly created application portal in Great Britain (OPSS). All cosmetic products before being placed on the market need to be notified on the Cosmetic Products Notification Portal. This is the free of charge notification system created for the implementation of Regulations in EU and GB. Specific information about the cosmetic product must be entered into the system. This information is available for the Competent Authorities and Poison Centres or similar bodies for market analysis and medical treatment. CPNP and OPSS are not available to public access, only for the manufacturers, distributors, and Responsible Person. Each product should be notified once, and if any changes are made, for example in the formulation or label, should be corrected. The fact that the product has been notified through CPNP (or OPSS) does not mean that it complies with all requirements of the Regulation (EC) No 1223/2009. Cosmetics can be notified as single component product or a multi-component product, which should be understood as the set of cosmetics.
The following information should be submitted electronically prior to marketing:
These and other more specific data should be entered into notification system. After successful notification, the product can be placed on the market only if it complies with all EC requirements. Notification is equally as important as the Cosmetic Product Safety Report.
Compilation of product documentation (PIF product information file)
We complete, update, and manage documentation of a cosmetic product before it is introduced to the market. Before placing the cosmetic product on the market, it is required to provide a PIF - Product Information File. PIF is a key document that gathers all updated data for the product. This document must be kept for the time of 10 years by the Responsible Person.
Product Information file contains:
This documentation should be accessible at the address placed on the label - the address of the Responsible Person, where it should be kept.