Food Supplements

• Consulting and compliance with applicable legislation
  Support in understanding and implementing regulations and ensuring compliance with legislation applicable to food supplements (Directive 2002/46/EC, Regulation (EU) No. 1169/2011, Regulation (EU) No. 1924/2006, etc.).
• Review and consultation on health and nutritional claims Analysis and guidance on the use of permitted health and nutritional claims to ensure their correct and lawful use in advertising and product packaging.
• Compliance with local requirements
  Detailed explanations and guidance on specific requirements for marketing and selling food supplements in Slovenia, including a review of ingredient compliance.
• Registration of companies trading in food supplements
  Consulting on the registration of companies involved in the production or sale of food supplements, and assistance in meeting all necessary requirements to start operations in this field.
• Support during inspections
  Advice and support in the event of inspections by competent authorities to ensure fast and effective resolution of any issues or non-compliances.
• Labeling advice (preparation and review of declarations)
  Guidance on preparing, designing, and reviewing product labeling (declarations) to ensure compliance with legal requirements.
• Consulting on permitted substances in food supplements
  Advice and assistance in selecting and using legally permitted ingredients in food supplements, in line with EU and Slovenian regulations.
• Nutravigilance
  Support in monitoring the safety of food supplements and ensuring proper reporting of any adverse effects associated with their use.
• Monitoring changes and updates to legislation

Cosmetic Products

• Ingredient and labeling compliance
  Consulting and assistance in preparing packaging content and instructions for use.
• Notification via CPNP
  Support and consulting for product notification to the European Commission through the Cosmetic Products Notification Portal (CPNP), in accordance with Regulation (EC) No. 1223/2009 (Article 13).
• Consulting on permitted substances in cosmetic products
  Advice on permitted, restricted, and prohibited substances in accordance with Regulation (EC) No. 1223/2009 and its relevant annexes (lists of prohibited substances, colorants, preservatives, UV filters, etc.).
• Cosmetovigilance
  Support in monitoring adverse effects of cosmetic products and ensuring proper reporting of any undesirable effects associated with their use.

Biocidal Products

• Compliance with BPR
  Consulting and assistance in ensuring compliance with the Biocidal Products Regulation (BPR).
• Biocidal product notification
  Preparation of registration applications for biocidal products.
• Chemical safety adviser
  Provision of a responsible person (chemical safety adviser) in accordance with legislation and regulations.
• Registration of companies involved in the production, storage, and trade of hazardous chemicals
  Support in registering companies operating in the field of hazardous chemicals.
• Compliance with REACH, GHS, and CLP

• REACH – Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals.
• GHS – Globally Harmonized System of Classification and Labelling of Chemicals.
• CLP – Classification, Labelling, and Packaging of substances and mixtures.

Our team has deep and rich experience in providing different language translations.

Our company has experience to provide you with:

• Consultancy in advanced drug development projects, marketing authorisation strategies and procedures
• Local Qualified Personnel/Representatives

Please define the topic of interest and we will invite the regional/country KOLs and provide you with an answer you are looking for.