General and legal basis
According to §6c Health and Food Safety Act (GESG) and §25a Food Safety and Consumer Protection Act (LMSVG) the BAVG is responsible for the official control of consignments of consumer goods and cosmetic products entering the European Union via Austrian territory in close coordination and cooperation with the Federal Ministry of Finance (BMF/Customs Office Austria).
Please note in particular the following legal basis (as amended - Note: in the current version):
- §6c Health and Food Safety Act (GESG).
- §25a Food Safety and Consumer Protection Act (LMSVG)
- Product Safety Act 2004
- Regulation (EU) No. 2019/1020 (Market Surveillance Regulation)
- Regulation (EU) No. 1223/2009 on cosmetic products
- Regulation (EU) No. 284/2011 laying down special conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People's Republic of China and the Hong Kong Special Administrative Region, China, respectively
- Directive 2002/72/EC on plastic materials and articles intended to come into contact with foodstuffs
- Directive 2009/48/EC on the safety of toys
Conformity of products
This Article applies only to products covered by Regulations (EU) no. 305/2011 (34), (EU) 2016/425 (35) and (EU) 2016/426 (36) of the European Parliament and of the Council and Directives 2000/14/EC (37), 2006/42/EC (38), 2009/48/EC (39), 2009/125/EC (40), 2011/65/EU (41), 2013/29/EU (42), 2013/53/EU (43), 2014/29/EU (44), 2014/30/EU (45), 2014/31/EU (46), 2014/32/EU (47), 2014/34/EU (48), 2014/35/EU (49), 2014/53/EU (50) and 2014/68/EU (51) of the European Parliament and of the Council.
With regard to the conformity of products according to Article 4 of the Market Surveillance Regulation (Regulation (EU) No. 2019/1020), the economic operator has to ensure that either an EU declaration of conformity or a declaration of performance including technical documentation is available. These must be kept available for the market surveillance authorities and must be made available immediately upon request. All relevant information and documentation required to demonstrate the conformity of the product shall be provided to the authority in an easily understandable language. If there are reasons to believe that a particular product presents a risk, the market surveillance authority must be informed immediately. In case of non-conformity, the economic operator must independently, but also upon request of the market surveillance authority, set immediate corrective actions to mitigate the risk. The name, registered trade name or registered trade mark and contact details including the postal address of the economic operator must be indicated on the product, packaging, package or in an accompanying document.
Chapter II Obligations of the economic operators
Obligations of manufacturers (Art.4):
- When a toy is placed on the market, the manufacturer undertakes that it has been designed and manufactured in accordance with Article 10 and Annex II.
- The manufacturer shall draw up the technical documentation required under Art. 21 and shall carry out the conformity assessment procedure to be applied under Art. 19. or have it carried out.
- Where the product complies with the applicable requirements, manufacturers shall draw up an EC declaration of conformity (Art.15) and affix the CE marking (Art. 17).
- The toy must be accompanied by instructions for use and safety information (in the language of the consumer or in one that can be understood by the consumer).
Obligations of importers (Art. 6):
- Importers shall place only compliant toys on the market and shall ensure that the conformity assessment procedure has been carried out by the manufacturer before placing the toy on the market.
- Where the product presents a risk, importers shall inform the manufacturer and the market surveillance authorities to that effect.
- They shall immediately take any necessary corrective action to bring the toy into conformity or, if appropriate, recall it and inform the competent national authorities of the Member States without delay.
Obligation of distributors (Art. 7):
- Distributors shall verify, before making a toy available on the market, that the toy bears the required conformity marking, is accompanied by the required documentation and instructions for use and safety information, and that manufacturers and importers have complied with your requirements of Article 4(5) and (6) and Article 6(3) (see above).
Circumstances in which the manufacturer's obligations also apply to importers and distributors (Art. 8):
An importer or distributor shall be considered a manufacturer and be subject to the obligations for manufacturers under Article 4 where it places a toy on the market under its own name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements may be affected.
Chapter III - Conformity of the toy
Essential Safety Requirements (Art. 10.):
Only toys that comply with the essential safety requirements may be placed on the market:
- Toys, including the chemical substances they contain, must not endanger the safety or health of users or third parties when used as intended or in a foreseeable manner and taking into account the behavior of children
- Consideration of the ability of users or those supervising them (especially for under 36 months or for certain age groups).
- Labels and the accompanying instructions for use must draw attention to the hazards and risks associated with its use, as well as to ways of avoiding them
- Safety requirements must be met during the foreseeable and normal period of use of the toy
EC Declaration of Conformity (Art. 15):
- The EC declaration of conformity states that compliance with the requirements set out in Article 10 and Annex II has been demonstrated
- The EC declaration of conformity shall contain at least the elements specified in Annex III and shall be kept up to date and conform in its structure to the model set out in Annex III and shall be translated into the language or languages required by the Member State in which the toy is marketed or made available on its market
By issuing the EC declaration of conformity, the manufacturer assumes responsibility for the conformity of the toy!
General principles of CE marking (Art. 16):
- All toys made available on the market must bear the CE- marking (principles according to Article 30 of Regulation (EC) No. 765/2008).
Rules and conditions for affixing the CE marking (Art. 17):
- The CE marking shall be affixed visibly, legibly and indelibly to the toy, to a label attached to it or to the packaging. In the case of small toys, the CE marking may be affixed either on a label or on an accompanying leaflet
- If this is not technically possible when selling toys with counter presentation packaging that carries the product, and the counter presentation packaging was originally used as packaging for the toy, the information shall be affixed to the presentation packaging
- If the CE marking of a packaged toy is not visible from the outside, it shall at least be affixed to the packaging
The CE marking shall be affixed before the toy is placed on the market.
Formal non-conformity (Art. 45):
- the CE marking has not been affixed in accordance with Article 16 or 17
- the CE marking has not been affixed
- the EC declaration of conformity has not been drawn up
- the EC declaration of conformity has not been drawn up correctly
- the technical documentation is either not available or not complete
Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take appropriate measures to restrict or prohibit the toy being made available on the market or to ensure that it is recalled or withdrawn from the market.
List of products which are not considered to be toys, in particular for the purposes of this Directive
SPECIFIC SAFETY REQUIREMENTS
- Physical and mechanical properties
- Chemical properties
- Electrical properties
List of CMR substances and their permitted uses according to points 4, 5 and 6 of Part III
CLASSIFICATION OF SUBSTANCES AND MIXTURES
Specific limit values established in accordance with Article 46(2) for chemical substances used in toys intended for use by children under 36 months of age or in other toys intended to be placed in the mouth
EC DECLARATION OF CONFORMITY
Part A: General warnings
Part B: Special warnings and instructions for use for certain categories of toys
- Toys not intended for use by children under 36 months of age
- Activity toys
- Functional toys
- Chemical toys
- Ice skates, roller skates, in-line skates, skate boards, scooters and toy bicycles for children
- Water toys
- Toys in food
- Imitation protective masks or helmets
- Toys designed to be attached to cradles, cribs or strollers by means of strings, straps, elastic bands or belts
- Packaging for fragrances in board games for the sense of smell, cosmetic cases and games for the sense of taste
- Cosmetic products made available on the market shall be safe for human health under normal or reasonably foreseeable conditions of use.
Obligations of responsible persons (Art. 5):
Definition (Art.4): responsible person ensures compliance with the relevant obligations set out in this Regulation:
- within the EU: manufacturer
- for an imported cosmetic product: importer
- if he places a cosmetic product on the market under his own name and trademark: Distributor
- take corrective action when there is reason to believe that a cosmetic product they have placed on the market does not comply with this Regulation (establishment of conformity, recall, ...).
- In case of risk to human health, immediately notify the national competent authorities of the Member States where they have made the product available on the market; including detailed information, in particular on the non-compliance and the corrective actions taken
- cooperate with the authorities and provide them, further to a reasoned request from the latter, with all the information and documentation necessary to demonstrate the conformity of the product.
Obligations of distributors (Art. 6):
Before making a cosmetic product available on the market, distributors shall verify that
- the labeling information is available
- the language requirements are met
- if applicable, the best-before date has not expired
Safety assessment (Art. 10):
- In order to demonstrate the conformity of the cosmetic product, before placing a cosmetic product on the market, the responsible person shall ensure that the cosmetic product has undergone a safety assessment based on the relevant information and that a cosmetic product safety report has been prepared in accordance with Annex I.
Annex I PART B - Cosmetic Product Safety Assessment
Production File (Art. 11):
When a cosmetic product is placed on the market, the responsible person shall keep a product information file on it, which shall be kept for a period of 10 years (after the last batch of the cosmetic product has been placed on the market). It contains the following information:
- Description of the cosmetic product (clear classification must be given)
- Safety report (according to Art. 10)
- Description of the manufacturing method and compliance with good manufacturing practice.
- If justified, evidence of the claimed effect
- Data on the manufacturer, distributor or supplier related to the development or safety assessment; including any animal testing to comply with third country legislation
Restriction of certain substances (Art. 14):
- Prohibited substances (Annex II)
- Restricted substances
- UV filters
LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MAY CONTAIN ONLY IN COMPLIANCE WITH THE RESTRICTIONS INDICATED
LIST OF COLORANTS AUTHORIZED IN COSMETIC PRODUCTS
LIST OF PRESERVATIVES AUTHORIZED IN COSMETIC PRODUCTS
LIST OF UV FILTERS AUTHORIZED IN COSMETIC PRODUCTS
Animal testing (Art. 18.):
It is prohibited:
- The placing on the market of cosmetic products the final composition of which, in order to comply with the provisions of this Regulation, has been determined by animal testing using a method other than an alternative method, after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD.
- the placing on the market of cosmetic products, the ingredients or combinations of ingredients of which have been determined by animal testing to comply with the provisions of this Regulation, using a method other than an alternative method, after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD
- the performance of animal testing of finished cosmetic products within the Community for compliance with the provisions of this Regulation
- the performance of animal testing of ingredients or combinations of ingredients within the Community in order to comply with the provisions of this Regulation.
Information for consumers
Labelling (Art. 19):
Containers and packaging of cosmetic products shall bear the following information in an indelible, easily legible and clearly visible manner:
- Name or business name and address of the person responsible.
- imported cosmetic products: country of origin
- the nominal content at the time of filling, by weight or volume (except for packages >5g/ml, free samples...)
- for bulk packages: Number of pieces
- best before date ("best before")
- minimum shelf life of more than 30 months: how long the product is safe after opening and can be used without harm to the consumer
- special precautions
- Batch number
- intended use
- a list of ingredients ("Ingredients")
- fragrance and aroma substances and their source materials: "perfume" or "aroma
- nanomaterials: "nano
SYMBOLS USED ON PACKAGING/CONTAINERS
LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING
Plastic articles made of polyamide and melamine
Commission Regulation (EU) No 284/2011 laying down special conditions and detailed procedures concerning the import of polyamide and melamine plastic kitchenware originating in or consigned from the People's Republic of China or the Hong Kong Special Administrative Region, China.
The inspection shall be carried out at the designated place of first introduction. It shall include document verification, identity checks and commodity testing (including laboratory analysis of 10% of the consignments). During the examination of the sample, the consignment is blocked.
The performance of the official control is to be requested at the border inspection post 2 days in advance by presenting the declaration in the annex of the Regulation (EU) No. 284/2011 together with the corresponding laboratory reports by means of GGED-D (Common Health Entry Document).
The laboratory reports are to be sent by mail to email@example.com.