Approved methodological recommendations by the Ministry of Health on borderline products

By Order of the Ministry of Health of Ukraine No. 1247 dated July 17, 2024, the methodological recommendations for the application of the Technical Regulation on cosmetic products concerning borderline groups of cosmetic products have been approved.

The Technical Regulation defines a cosmetic product as “any substance or mixture intended for application to various external parts of the human body (epidermis, hair, nails, lips, external genital organs), teeth, and the mucous membranes of the oral cavity solely or predominantly for the purpose of cleaning, perfuming, changing their appearance, protecting them, keeping them in good condition, or correcting body odors.”

At the same time, there are instances when there is uncertainty regarding the classification of certain products as cosmetics or other types of products according to other sectoral legislation (medicinal products, medical devices, disinfectants, toys, etc.). Such products are called “borderline products.” These products can be regulated by several regulatory acts simultaneously within their scope of application, for example, sunscreens with insect repellents, children’s cosmetics, etc.

The Methodological Recommendations are a collection of practical examples of the application of legislation in each specific case and consider the following types of products:

• Tongue brushes that release a substance or mixture
• Clothing that releases a substance or mixture
• Toothpicks and dental floss
• Patches
• Washable, temporary “tattoos”
• Wipes
• Wigs
• Tattoo removal devices
• Wet razors that release substances/mixtures
• Products for masking bad breath
• Products intended for cleaning and use for the vagina
• Nasal sprays
• Chewing gum for maintaining teeth cleanliness or reducing bad breath
• Tablets for masking bad breath
• Tooth whitening products placed inside the tooth
• Products for use as makeup on dolls
• Products intended for use as children’s makeup
• Bath products for children with a play function
• Face paints, body paints, airbrushes
• Leave-on skin products presented as “antiseptic” or “antibacterial”
• Products for relieving joint pain
• Products intended for itching relief
• Products containing substances that restore, correct, or change physiological functions through pharmacological, immunological, or metabolic actions
• Products containing substances that stimulate hair growth or reduce hair loss
• Products that stimulate eyelash growth
• Products for ingrown hairs
• Products for lip enhancement
• Products that reduce cellulite
• Substances applied via patches
• Products delivered through iontophoresis or similar mechanisms
• Products delivered through invasive methods, such as needle rollers
• Products for treating dry mouth
• Products for superficial moisturization of female genital organs in case of excessive dryness of the mucous membrane
• Topical products for breast enlargement
• Products claiming to provide aromatherapy
• Products for atopic skin
• Products to reduce dark circles under the eyes, bruises, or blue spots
• Products with claims related to bruises, bumps, and similar conditions
• Skin whitening products
• Products to relieve fatigue, swelling, and heaviness in the legs
• Anti-wrinkle products
• Tattoo removal products
• Products claiming “skin health improvement”
• Tanning products
• Products for removing “hard skin”
• Products for changing the appearance of skin redness due to weak dilation or imperfection of capillary veins
• Skin care products after tattoos
• Acne and blemish products
• Piercing care products
• Mouth rinses and dental gels
• Nail care products
• Massage products
• Skin peeling products
• Anti-lice products
• Styptic pencils
• Products intended to detect dental plaque
• Products designed to remove adhesive used to fix cosmetic products on the skin
• Products intended to stimulate sexual activity
• Essential oils
• Products designed to imitate wounds, scars, warts, etc.
• Cosmetic kits
• Dual-purpose soap (for personal hygiene and laundry)

Decisions regarding the classification of a product should be made in each specific case, taking into account all the product’s characteristics, including its purpose, function, place of application, composition, claims made about the product, and its overall presentation.

The Methodological Recommendations are not a regulatory legal act, do not establish legal norms, and are informational and recommendatory in nature. However, they will be used by authorized bodies in matters of technical regulation and state market supervision.

Our services

Cratia provides comprehensive regulatory support and accompanies at all stages of regulatory compliance of cosmetic products in Ukraine:

• outsourcing of a Responsible Person (RP) in Ukraine;
• assessment of the composition of the product;
• filling of the Product Information File;
• Cosmetic Product Safety Report (CPSR);
• verification/development of labeling, instructions, and advertising materials;
• product notification;
• development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
• legal and consulting support of the manufacturer, Responsible person or distributor (importer).

We possess deep knowledge and experience, speak and write fluent English. We will take over the organization of the process, assist in filling of the set of documents and perform the required procedures in a short time.