Europe Regulatory News

On 17 March 2020 the Eu Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner: In paragraph 3 of point 11...

On 17 March 2020 the Eu Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner:

In paragraph 3 of point 11 of Part III of Annex 2 of Directive 2009/48/EC (list of allergenic fragrances the name of which shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet if added to a toy at concentrations exceeding 100mg/kg):

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Some chemicals are source of increasing concern as they can cause allergic reactions after skin contact. In view of the likely exposure to sensitising chemicals foun...

Some chemicals are source of increasing concern as they can cause allergic reactions after skin contact. In view of the likely exposure to sensitising chemicals found in textiles, leather, hide and fur articles, the Swedish Chemicals Agency (KemI) and the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) analysed several risk management options and proposed a restriction under REACH as the most appropriate measure to manage the possible risks that such chemicals pose to citizens. The Committee for Socio-economic Analysis (SEAC) also supports France and Sweden’s proposal to limit the use of skin sensitising substances in clothing, footwear and other articles with similar skin contact. 

KemI and ANSES’s proposal pursues to limit the concentrations of substances that have a harmonised classification as skin sensitisers in Categories 1/1A/1B listed in the CLP Regulation and that are present in these articles. It also covers disperse dyes which may cause allergic skin reactions – even if the dyes do not have a harmonised classification as skin sensitisers. 

The proposal introduces a link with the CLP Regulation meaning that any substance that is classified as a skin sensitiser in the future under CLP would automatically be covered by the restriction. When substances are automatically added to the restriction, SEAC recommends a transitional period of three years between classification and the conditions of the restriction taking effect to allow manufacturers to adapt. 

SEAC adopted its final opinion on France and Sweden’s proposal to restrict skin sensitising substances in textile, leather, synthetic leather, hide and fur articles, that are placed on the market for the first time. This further follows an earlier opinion by the Committee for Risk Assessment (RAC) in March 2020 and both committees concluded that an EU-wide restriction is the most appropriate means to address the risks to EU citizens. 

In their September meetings, RAC and SEAC also discussed applications for authorisation, other restriction proposals and harmonised classification and labelling which included following conclusions. 

• SEAC agreed its final opinion on ECHA’s proposal to restrict the placing on the market of calcium cyanamide used as a fertiliser.  
• SEAC adopted its final opinion on ECHA’s proposal to restrict five cobalt salts i.e. Cobalt carbonate, Cobalt diacetate, Cobalt dinitrate, Cobalt sulphate and Cobalt dichloride. As all of them are classified as carcinogenic, mutagenic and reprotoxic (CMR).  
• SEAC accepted its final opinion on ECHA’s proposal to restrict formaldehyde in articles, road vehicles and aircraft. 
• SEAC also received an update on the consultation comments received on ECHA’s proposed restriction of intentionally-added microplastics. The 60-day consultation on SEAC’s draft opinion ended on 1 September 2020, with 211 comments received. SEAC is expected to adopt its final opinion in December 2020. 

On October 14 the European Commission published the comprehensive Chemical strategy (EU Chemicals Strategy for Sustainability). The Strategy is the first step toward a zero pollution ambition outlined...

On October 14 the European Commission published the comprehensive Chemical strategy (EU Chemicals Strategy for Sustainability). The Strategy is the first step toward a zero pollution ambition outlined in the European Green Deal. The strategy covers a variety of dimensions, including non-toxic material cycles, banning the most harmful chemicals in consumer products, phasing out the use of per- and polyfluoroalkyl substances (PFAS) in the EU, establishing a simpler “one substance one assessment” process for the risk and hazard assessment of chemicals.

The Strategy is expected to boost innovation for safe and sustainable chemicals and increase protection of human health and the environment against hazardous chemicals.

In case of import, UFI can be used in the communication with a non-EU supplier. The following way can be considered to work around possible communication problems (e.g. if the non EU supplier intends ...

In case of import, UFI can be used in the communication with a non-EU supplier. The following way can be considered to work around possible communication problems (e.g. if the non EU supplier intends to protect the confidentiality of the mixture information).

The non–EU supplier has a legal entity based in the EU (or a contractual agreement with an EU-based legal entity), which creates a UFI and makes a submission voluntarily 33 to the Member States where the EU importer intends to place the mixture on the market. The non-EU supplier informs their customer (the EU-importer, directly or via the EU-based legal entity) about this UFI and confirms that the submission is done. Subsequently, the EU importer, who is the actual duty holder, makes their own submission with a reference to this UFI in relation to the compositional information. The importer could therefore make a submission for a mixture containing 100% of the MiM supplied by the non-EU supplier. This option could be useful also when the EU importer uses the mixture to formulate another mixture, and the non-EU supplier wants to protect the confidentiality of the information on the mixture they supply to the EU importer. The obligation to place UFI on the label lies with the EU importer. It is possible for the non-EU supplier to already label their product with the correct UFI before supplying it to the EU importer.

The EU importer and non-EU supplier are strongly recommended to enter into a contractual agreement to cover the details of the submission approach chosen. It should be kept in mind that the EU importer remains in any case the duty holder and therefore responsible in front of the enforcement authorities. Furthermore, the EU importer remains responsible for the fulfilment of other obligations under CLP (e.g. classification of the mixture).

We are delighted to announce that Sustainability Support Services (SSS) Europe AB has recently changed its registered name to Global Product Compliance (GPC)Europe AB as part of the recent acquisition by the Global Regulatory Compliance Holding.

The new name GPC Europe AB will be officially effective from 1st July 2020. Wherein,

No change is applicable to the

1. Legal Entity Number
2. Bank Name and Account Number
3. Management, professional team, and contact persons for your organization.

The changes that would be affected are:

1. Company Logo
2. The website changed to gpcgateway.com
3. Executives email changed to xyz@gpcregulatory.com
4. LinkedIn page changed to the GPC Group.

Read more here

The additions include three substances that are toxic to reproduction and one endocrine disruptor. The Candidate List of substances of very high concern (SVHCs) now contains 209 substances that may ha...

The additions include three substances that are toxic to reproduction and one endocrine disruptor. The Candidate List of substances of very high concern (SVHCs) now contains 209 substances that may have serious effects on people or the environment.

Helsinki, 25 June 2020 – The endocrine-disrupting substance is used in consumer products, such as cosmetics. The three others are used in industrial processes to produce polymers, coating products and plastics, respectively. 

Companies are urged to check their legal obligations relating to the safe use of their substance. From January 2021, companies will also have to notify products containing SVHCs to ECHA’s upcoming SCIP database on substances of concern in articles and products. The database aims to ensure transparent information on articles containing hazardous chemicals throughout their whole lifecycle.

ECHA’s Director of Hazard Assessment says: “Chemicals on the Candidate List  are among the most regulated in the EU, and our aim is to gradually phase them out. In the meanwhile, companies need to ensure their safe use and be transparent towards consumers who have the right to know where these chemicals are used. Substituting them with safer alternatives can boost innovation and create a more sustainable circular economy.”

Substances added to the Candidate List for authorisation on 25 June 2020:

ECHA’s Member State Committee was involved in the decision to include butyl 4-hydroxybenzoate and dibutylbis(pentane-2,4-dionato-O,O')tin to the list.  

Background

The Candidate List includes substances of very high concern that may have serious effects on our health or environment. These may be placed on the Authorisation List in the future, which means that industry would need to apply for permission to continue using them.

Companies may have legal obligations when their substance is included in the Candidate List - either on its own, in mixtures or in articles. Any supplier of articles containing a Candidate List substance above a concentration of 0.1 % weight by weight has to give sufficient information to their customers and consumers to allow safe use. As of January 2021, companies will also need to notify ECHA’s SCIP database if their articles contain Candidate List substances.

Importers and producers of articles containing a Candidate List substance also have six months from the date of its inclusion in the list (25 June 2020) to notify ECHA.

More information on these obligations and related tools are available on ECHA’s website.

Candidate List substances: overview of hazardous properties

Of the 209 substances now on the Candidate List of SVHCs for authorisation, a large majority are carcinogenic, mutagenic or toxic to reproduction. Many of them have several hazardous properties.