Simplification of certain requirements and procedures for chemical products (Omnibus VI)
The Committee on the Environment, Climate and Food Safety and the Committee on the Internal Market and Consumer Protection jointly adopted the report by Dimitris TSIODRAS (EPP, EL) and Piotr MÜLLER (ECR, PL) on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products.
The committees responsible recommended that the European Parliament adopt its position at first reading as follows:
Amendments to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
- the term digital contact is clarified to mean any up-to-date easily and freely accessible online communication channel such as email addresses or a weblink through which a supplier can be contacted without the need to register or to download or use an application. The telephone number may be omitted from the label if it is directly available via the digital contact details;
- by 18 months from the date of the entering into force of this Amending Regulation, the Commission will carry out an assessment on whether further specific reductions of mandatory label elements should apply to packages between 10 and 125 ml;
- the label elements may be reduced where: (a) the content of the packaging of a substance or a mixture does not exceed the required quantities; and (b) the packaging is either in such a shape or form or is too small in size to allow for a full reference to all the elements referred to in Article 31 in all the languages of the Member State in which the substance or mixture is placed on the market;
- suppliers should be allowed to reduce hazard information on the label of ink cartridges intended for use in a printer, under certain conditions;
- the updated rules regarding label revisions require updates without undue delay and at the latest within 18 months per actor in the supply chain;
- any advertisement to the general public for a substance or a mixture classified as hazardous must include the applicable hazard pictogram(s) or the relevant signal word. The does not apply to advertisements to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, provided that the advertisement is not targeted at or directly made available to the general public;
- when substances or mixtures are placed on the market for the general public through distance sales, the offer will clearly and visibly indicate the label elements. This also applies to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer allows a member of the general public to conclude a distance contract.
Amendments to Regulation (EC) No 1223/2009 on cosmetic products
Substances classified as CMR category 1A or 1B may be used in cosmetic products exceptionally if a derogation request is submitted to the Commission and the Commission grants the derogation from the general prohibition laid down in the regulation. The Commission may grant the derogation where the substances have been evaluated and found safe by the SCCS for one or more particular uses of one or more cosmetic product categories considering overall exposure from the uses in those products categories as well as from sources other than cosmetics and of vulnerable population groups.
The proposed amendments stipulate that the use of any alternative substance to replace the classified substance is safe for human health. The alternative should provide an equivalent function and comparable level of efficacy and performance and should be available on the market in sufficient quantities, or likely to be available in sufficient quantities to meet current demand and has the demonstrated potential to meet expected demands in a reasonable timeframe. Its use should be technically and economically feasible for businesses and especially for SMEs to allow sustained production.
Cosmetic products containing prohibited or non-compliant carcinogenic, mutagenic and reprotoxic substances may remain temporarily on the market following a regulatory change, with the timeframe varying depending on the situation:
- if no derogation request was submitted: a period of 6 months for placing and 15 months for making available on the market;
- request for derogation if the substance is not safe: 3 months for placing and 12 months for making available on the market;
- request for derogation if the substance is safe, but the request has been refused due to the availability of suitable alternatives: 24 months for placing and 48 months for making available on the market, under the condition that an up-to-date product safety report remains available at all times.
Cosmetic products containing nanomaterials will be notified to the Commission by the responsible person by electronic means prior to being placed on the market. The information notified to the Commission will contain at least the identification of the nanomaterial and the specification of the nanomaterial including size of particles, physical and chemical properties.
Regulation (EU) 2019/1009 on fertiliser products
The amended text specifies that manufacturers should ensure that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be directly accessed.
For the purposes of this Regulation, products derived from animal by-products that are used solely as component materials in EU fertilising products may be made available on the market only where they originate from animal by-products or derived products that have reached an end point in the manufacturing chain in accordance with Article 5(2) of Regulation (EC) No 1069/2009.
The Commission will periodically assess whether the requirements governing the treatment of materials intended for use in fertilising products remain appropriate and, where necessary, adapt them in light of scientific and technical advances.
This review will be carried out for the first time no later than two years after the date of application of this amending Regulation.