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 General Product Safety Directive (GPSD) 2001/95/EC is a critical regulation within the European Union (EU) that mandates the safety of consumer products sold across the EU market. The directive applies broadly to products not covered by specific sectoral legislation, ensuring that goods such as electrical items, toys, cosmetics, and various household products meet the necessary safety standards. Compliance with the GPSD is essential for protecting consumers, mitigating legal risks, and maintaining market access.
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 general products are safe and able to be placed on the EU market.
The regulatory services for GPSD (General Product Safety Directive):
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:
- Formula Review & Safety Assessment: Includes the hazard classification and labeling, packaging information, risk assessment and warnings.
- 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:
- 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.
- 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:
- 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. - 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
Lastly, an EU Authorized Representative (AR) is mandatory for compliance with the GPSD
An Authorized Representative (AR) under the GPSD is a crucial entity for non-EU manufacturers seeking to enter the EU market. The AR ensures regulatory compliance, maintains necessary documentation (such as the EU Declaration of Conformity), and liaises with market surveillance authorities. This role is essential for bridging the regulatory gap and ensuring that products adhere to EU safety standards.
Key Aspects of the General Product Safety Directive (GPSD):
- Objective: The GPSD aims to ensure that only safe products are available in the EU market, safeguarding consumers from potential hazards.
- Scope:
- The GPSD covers a wide range of consumer products, including household goods, toys, clothing, personal care items, and more.
- It also applies to products with partial coverage under other legislation, ensuring comprehensive safety standards.
- Safety Requirements:
- Products must be safe under normal or foreseeable use conditions.
- Safety is assessed based on national regulations, European standards, or other relevant criteria, including product characteristics, packaging, and instructions.
- Obligations for Economic Operators:
- Manufacturers: Must ensure product safety before market entry, provide usage information, and monitor post-sale safety.
- Importers: Must verify that products from outside the EU meet EU safety standards.
- Distributors: Are responsible for ensuring that the products they supply are safe.
- Market Surveillance and Enforcement:
- EU member states must establish systems to monitor product safety and take action against unsafe products, including recalls and bans.
- RAPEX System:
- The RAPEX system enables the rapid exchange of information between EU countries about dangerous non-food products, facilitating swift market withdrawal or recall.
- Consumer Rights:
- The GPSD ensures that consumers are protected by the right to safe products and are informed about risks and corrective measures when necessary.
Importance of GPSD Compliance
The GPSD is vital for maintaining high consumer protection standards within the EU, fostering confidence in product safety, and preventing harm from unsafe goods. Ensuring compliance with this directive is essential for any business aiming to market consumer products in the EU.
For assistance with GPSD compliance, contact BIORIUS to safeguard your products and avoid regulatory pitfalls.