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Regulatory Context

What is a General Product?

The General Product Safety Directive defines a general product as “any product — including in the context of providing a service — which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned.”

The scope of this definition applies to electrical and electronic goods, cosmetics, toys, and other specific product groups in the European Union.

 

 

What are the general product categories?

General product safety can be assessed in three main categories: objects, candles & room fragrances and aromatherapy.

  • Tools, sponges, patches, brushes, etc., are considered ‘general products’ and more specifically ‘objects’.
  • Room fragrances, candles, sprays, and diffusers are considered ‘substances/mixtures applied by inhalation’.
  • Aromatherapy, well-being and mood-enhancing products are considered ‘substances/mixtures applied on the skin’.

These three categories fall under the General Product Safety Directive 2001/95/EC.

Objects are also required to be compliant and labeled according to the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008).

Scented products (non-cosmetic) are required to be classified, and if hazardous, labeled according to the same Classification, Labelling and Packaging (CLP) Regulation.

This regulation is applicable to EU member states and to all industrial sectors. It requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market.

BIORIUS can help ensure that your products are safe and able to be placed on the EU market.

Objets (make-up tools)

The regulatory process for objects consists of a formula review, a safety assessment, and a label review, following the above-mentioned regulation. The Responsible Person for this product category is the importer. The process is thus divided into two phases:

  1. Formula Review & Safety Assessment: Includes the hazard classification and labeling, packaging information, risk assessment and warnings.
  2. Label & Claims Review: Evaluation of the product label (required information, symbols and claims).

Upon conclusion of the evaluation, a report is issued, which highlights the following points:

  • Required elements
  • Presence of required elements (primary packaging, secondary packaging & leaflet)
  • Symbols
  • Claims
  • Substantiation
  • Expert comments – strategic recommendations for updating the labels

Candles & Room Fragrances

The regulatory process for candles and room fragrances consists of a formula review, a risk assessment and a label review, following the above-mentioned regulation. The Responsible Person for this product category is the importer. The process is thus divided into two phases: the risk assessment (including a formula review) and the label review:

  1. Formula Review & Risk Assessment: A toxicological assessment of the substances in each ingredient, identification and classification of hazards. The corresponding warnings and symbols are provided upon conclusion of the evaluation.
  2. Label & Claims Review: Evaluation of the product label (required information, symbols and claims).

Upon conclusion  of the evaluation, a report is issued, which highlights the following points:

  • Required elements
  • Presence of required elements (primary packaging, secondary packaging & leaflet)
  • Symbols
  • Claims
  • Substantiation
  • Expert comments – strategic recommendations for updating the labels

Substances and mixtures applied on skin – Aromatherapy

The regulatory process performed on those products consists of a formula review, a risk assessment and a label review following the above-mentioned regulations. The responsible person for this product category is the importer. The process is thus divided into two phases: the risk assessment, including a formula review, and the label review:

  1. Formula Review & Risk Assessment: A toxicological assessment of the substances in each ingredient, identification, and classification of hazards while taking into consideration applies to the skin.
    The corresponding warnings and symbols are provided upon the conclusion of the evaluation.
  2. Label & Claims Review: Evaluation of the product label (required information, symbols and claims).

Upon conclusion of the evaluation, a report is issued, which highlights the following points (a table indicating the following elements is also sent to the client):

  • Required elements
  • Presence of required elements (primary packaging, secondary packaging & leaflet)
  • Symbols
  • Claims
  • Substantiation
  • Expert comments – strategic recommendations for updating the labels

Get in Touch

Need a piece of advice, a quotation or answers to your questions? Contact us…

Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!

As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

  • First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
  • 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
  • A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
  • No hidden costs: Biorius does not charge you for any question, call, or meeting.
  • A best-in-class IT tool, free of charge, and saving a lot of your time.
  • More than 1,500 international clients have already chosen Biorius!
  • We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.

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