Europe Reach Regulation for Various Sectors

Under Annex VIII to the CLP Regulation, importers and downstream users placing hazardous mixtures on the EU market are to provide specific information on their mixtures to appointed bodies. The annex also specifies a harmonised format for notifications. The information contained in the notifications will be used by poison centres for emergency health response purposes in case of incidents involving these mixtures.

The obligation applies to mixtures placed on the market that are classified for human health or physical hazards.

Note that biocidal products and plant protection products are within the scope of this obligation, and the information submission requirements apply in addition to other obligations under the Biocidal Products Regulation and Plant Protection Products Regulation.

Exemptions

The obligation to submit information does not apply to mixtures considered hazardous only due to environmental hazards. Mixtures exempted from the submission requirements include also:

• radioactive mixtures;
• mixtures subject to customs supervision;
• mixtures used in scientific research and development;
• medicinal and veterinary products, cosmetic products, medical devices and food and feeding stuffs; and
• mixtures only classified as gases under pressure and explosives.

For all ‘new’ products not already notified under national legislation, you must submit the required information before you place the mixture on the market. Submissions should be made in the harmonised format, according to the relevant date of applicability. The date of applicability depends on the use type, i.e. the end user, of the mixture:

1 January 2021 for consumer or professional use;

1 January 2024 for industrial use.

Before these dates, mixtures may be subject to existing national requirements and duty holders should contact the appointed body in the country of interest for further information.

• Legal entities on behalf of duty holders, such as consultant, mother company, i.e. ‘Foreign user’

• Importers or downstream users of mixtures out of scope i.e. a voluntary submission

• Legal representative of non-EU suppliers can also submit through the EU legal entity

1. Guidance on PCN requirements

2. Assess the portfolio to identify the

• Notification Requirements

• Trade names and Brand

• Country specific variations

• Use specific variations

• Components specific variations

3. Possibility to group and optimize the Notifications

4. Generate the UFI core for the Mixture

5. Verify the UFI in cases of Mixture (external) in Mixtures

6. Inventory data to support classification & Labelling of Mixture

7. Guidance on Packaging – type, and size requirements

8. Update SDS to harmonized with Poison Centre Notified information

9. Revised and updated PCN Notification submission

10. Portfolio management in PCN portal

Any chemical material/object containing chemicals placed into EU market need to comply with the REACH regulation. The chemical substances have the registration obligation whereas objects/articles containing chemicals have separate set of obligation.  

The Database for Substances of Concern In articles as such or in complex Products (SCIP) was established under the Waste Framework Directive (WFD) that aims to reduce hazardous chemicals in waste and promote safer alternatives. It is part of the EU’s waste legislation package, contributing to the EU's circular economy policy. 

The SCIP database ensures that the information on objects/articles containing Substances of Very High Concern (SVHC) is available throughout the whole lifecycle of products and materials, including at the waste stage.  

The following substances may be identified as SVHCs:  

• Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation. 

• Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII. 

• Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances. 

Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance as per Article 33(1) of the REACH regulation, such as: 

• supplying a safety data sheet 

• communicating on safe use 

• responding to consumer requests within 45 days and 

• notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w). 

From 5th January 2021, information about articles containing substances of very high concern (SVHCs) in a concentration above 0.1% weight by weight (w/w) on the EU market must be submited to ECHA. From this date onward all EU producers, Assemblers, importers, and distributors (inside EU only) must notify to the SCIP database. 

* substances of very high concern (SVHC) for human health and environment 

From 5 January 2021, article information should be communicated. To successfully notify your article to the SCIP database there are several categories for which information needs to be provided: 

Category 1: Information on Article. 

• Information to identify the article (Identifiers): 

• Article name (mandatory) 

• Primary article identifier (EAN, GTIN, catalogue number, part number) (mandatory) 

• Other names and identifiers (optional) 

• Information to categorize the article (Categorization): 

• Article category (CN/TARIC code) (mandatory) 

• Production in the EU (required but not essential) 

• Characteristics that help to identify the particle article 

• picture, (optional) 

• dimensions, (optional) 

• color, (optional) 

• weight (optional) 

• Safe use instructions: how do you use this article safely? 

• Option 1: Provide safe use instructions (free text)  

• Option 2: Select “No need to provide safe use information beyond the identification of the Candidate List substance”  

• Disassembling instructions (optional) 

• Complex object component (only applies to complex objects): 

• Linked article (add a link to an existing article or create a new article to link with this complex object) 

• Number of units of the linked article in the complex object. 

Category 2: Concern elements (SVHC) 

• Candidate list substance  

• Concentration range, incl > 0.1% by weight and < 100% by weight 

• Material category and/or Mixture category (EUPCS) 

• Additional material characteristics. 

1. Did the EU ban Single-use plastics?

Yes, the EU has banned single-use plastic products to reduce the danger these non-recyclable products pose to our environment.

2. What is the new EU Single-use Plastic Directive about?

The new EU Single-use plastic directive is a further clarification of guidelines made by the European Commission on the regulation of single-use plastics in the European Union. This directive applies to all member states within the EU. This new directive was issued on 31st May 2021, and it is what we refer to as an explanatory manual with detailed examples of products included or excluded from this regulation.

3. When is the new directive’s deadline?

The Single-Use Plastics Directive (SUPD) was approved in May 2019, and by 3rd July 2021, the ban on single-use plastic products and marking requirements will come into force.

4. Are all plastics referred to as Single-use plastics?

No. According to the directive, plastics refer to materials that consist of polymer to which additives or other substances might have been added. Also, this can function as a primary structural component of final products, excluding natural polymers that have not been chemically modified.

Also, Single-use plastics are products made with plastic and used one time before being thrown away: no hope of reusing or recycling them. Single-use plastics are also known as ‘disposable plastics’.

5. What are the marking requirements provided by the directive?

From 3rd July 2021, all single-use plastic products placed in the market will have a marking, either on the packaging or the product itself. This marking only applies to the products that were listed in part D of Directive 2019/904. These products are sanitary towels, tampons, tampon applicators, wet wipes, tobacco products, and cups for beverages. Read more here.

6. Who are the affected parties?

The EU directive on Single-use plastics applies to all member states within the EU. However, non-EU countries are not bound by this regulation at all.

7. Which Single-use Plastics are specifically banned?

Here is a list of the banned single-use plastics:

• Plastic straws
• Plastic plates and cutlery
• Beverage stirrers
• Balloon sticks
• Cups, food, and beverage containers made with expanded polystyrene
• Products made of oxo-degradable plastic
• Plastic water bottles
• Plastic shopping bags

Although there are some significant plastic product exemptions, they are food containers that require further preparation of the food before it can be consumed, beverage cups & lids, and plastic bottles of over 3 liters.

To get a complete list,contact us at compliance@gpcregulatory.com

8. Why EU Single-use Plastic Directive?

Plastic now makes up 80 to 85% of marine litter, and of this, 50% are single-use plastics. The main objective of SUPD is to reduce and further prevent the impact these plastic products have on the environment, especially our human health and aquatic environments. It will also help the Member States have an extensive reduction in the consumption of these products by 2026, 2022 being the base year, that is, the first year in the years to follow.

9. What other options do food manufacturers and retailers have as replacements for plastic spoons used with single-serve containers?

Starting from 3rd July 2021, only cutleries approved by the directive will be allowed in restaurants, events, and retailers. The approved ones include paper and wooden cutleries that have no poly in the board or coating.

10.What is the next step to take (if there is any action point (s)?

• Yearly report by member states to the European Commission. 77% of single-use plastic products in the market must be recycled by 2025, and 90% of it by 2029.
• Member States need to put in place measures that will guarantee that single-use plastic products are no longer placed in the market starting from 3rd July.
• Member States should see to it that affected products are replaced with affordable alternatives.
• According to the list provided by the directive, Member States must ensure that concerned single-use plastic products placed in the market bear a marking either on them or their packaging.

Single-Use Plastics Directive (SUPD)

On the 31st of May 2021, the European Commission released a new directive on single-use Plastics. The new EU Single-Use Plastic Directive aims to make further clarifications about plastic products that fall within that category and give further explanation about its regulations and policies. 

The new directive further mentions the reporting format to be used by member states and the deadlines for submitting their reports to the commission. The directive applies to every product considered as single-use plastic within the EU.

By 3rd July 2021, the ban on single-use plastic products and marking requirements will come into force.

GPC prepares a summary report for your reference. Download it here. 

Persistent Organic Pollutants (POPs), also referred to as “emerging contaminants”, include a range of chemical substances from diverse applications, ranging from medicines, personal care, household cleaning products, lawn care, agricultural products, among others.

The toxicity of POPs has been long investigated, and researchers found that these chemicals may have long-range mobility and long-lasting duration, leading to environmental contamination and pollution. POPs are often classified as Substance of Very High Concern (SVHC) with hormone disruption consequences, bioaccumulation and biomagnification through the food chain. The presence of POPs in the environment and in human health can lead to several complications, from mild effects to more serious consequences, for example, reproductive disruptions and immunological disorders.

Since POPs are not easily broken down, a characteristic that guarantees its continuation in the environment, the contaminant consequences are still being investigated. In other words, the emerging contaminants are mainly not from new pollutants that recently entered the environment. Instead, there is a good understanding of contaminants, but the consequences to their exposure are still being discovered.

Countries have created a set of rules and regulations to regulate, control, and mitigate POPs use and its effects on the environment and on human health. The essence of these legislations is to eliminate the production, trading, and use of such chemicals, including storage and waste management.

International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties to reduce their emissions below 1990 levels.

The Stockholm Convention is an international conference specifically for POPs proposed in May 2001 in Sweden (complementing the Aarhus Protocol), entering into force in 2004. Among the objectives, the Stockholm Convention aims to:

• Prohibit, eliminate, and restrict several POPs in the production, use, import, and export.
• Ensure that waste containing POPs is managed safely and in an environmentally sound manner.
• Promote tools for information exchange, public access, awareness and education, research, development and monitoring, reporting, and implementation of plans to fight POPs pollution.

The Stockholm Convention is considered the main international instrument to address POPs. Most countries adhere to the Stockholm Convention.

The EU is a party to the United Nations Economic Commission for Europe (UNECE) Air Convention (renamed in 2020; previously the UNECE Convention on Long-Range Transboundary Air Pollution (CLRTAP)). The Air Convention’s 1998 Aarhus Protocol on Persistent Organic Pollutants obliges parties to reduce emissions of certain POPs and has banned or restricted the use of some compounds.

In 2001, the Stockholm Convention was adopted, building on the Aarhus Protocol to act on POPs at the international level. These pieces of legislation are implemented in the European Union by the POPs Regulation (Regulation EU 2019/1021 of the European Parliament and of the Council concerning Persistent Organic Pollutants - POPs).

The POPs Regulation reflects the international framework proposed by Aarhus Protocol and by the Stockholm Convention in the European Union. The main objective is to protect human health and the environment with specific control measures that:

• prohibit or severely restrict the production, placing on the market and use of POPs
• minimize the environmental release of POPs that are formed as industrial by-products
• make sure that stockpiles of restricted POPs are safely managed; and
• Ensure the environmentally sound disposal of waste consisting of or contaminated by POPs.

The European Chemical Agency (ECHA) makes available a database to list substances subject to the POPs Regulation. The list can be accessed here.

In February 2022, the European Commission (EC) proposed a draft on Corporate Sustainability Due Diligence (CSDD). This draft aims to create a just and sustainable economy with legislation that guarantees respect of human rights and environment in global value chains.

The EC Directive would apply for the following categories of companies:

• Group 1: All Limited Liability Companies (LLCs) based in the European Union, which have more than 500 employees and has a net turnover worldwide of more than 150 million Euros.
• Group 2: EU based Limited Liability Companies acting in high impact sectors, which have more than 250 employees and a has net turnover worldwide of more than 40 million Euros. For these companies rules will start to apply 2 years later than Group 1.
• Non-EU companies active in the European Union and with a turnover threshold aligned with Group 1 and 2, generated in the EU.

The companies must integrate due diligence into their company's policy. Furthermore, companies should investigate and identify actual or potential adverse human rights and environmental impacts Thus, preventing any potential impact or minimizing it. Moreover, companies are asked to set up and maintain a complaints procedure. Hence, monitoring effectiveness of the due diligence policy. Finally, companies should announce publicly that they are committed and following due diligence.

The EC Draft Directive suggests sanctions for those companies that do not comply with this legislation. The sanctions are not specified but they should be effective, proportionate and dissuasive Thus, in case that a company fails to meet its Human Rights and Environmental Due Diligence (HREDD) obligations and would cause any damages, the company would be liable for those damages.

The EC Directive will been presented to the European Parliament and the European Council for approval. Once adopted each Member State has two years to transpose the Directive into national law.

Companies need to act in accordance with the following steps in order to comply with the EC Directive:

1. Identify their company suppliers and define the nature of the connection between the supplier and the company.
2. Create HREDD policies and procedures and implement them into the company policy.
3. Set up a checklist for the company’s suppliers and assess their human rights and working environment.
4. Set up a program to regularly assess the human rights and working environment and conditions of the company’s suppliers.
5. Implement a system to take corrective action and manage it.
6. Create a system to manage compliance and respond to complaints.

Detergents are chemicals with intrinsic properties that have the potential to pose risks to human health and the environment. In order to be placed and move freely on the EU market detergents need to comply with Regulation (EC) No 648/2004 (the ‘Detergents Regulation’) from 2004. The regulation contains labelling and biodegradability requirements and phosphorous limits. 

The Detergents Regulation provides key provisions and harmonises rules that ensure the free movement of detergents and surfactants for detergents in the internal market while at the same time protecting the environment and human health. These rules apply to both consumer detergents (detergents sold to the general public) and to industrial or institutional detergents (detergents sold for professional use).

In particular, the Detergents Regulation harmonises the following rules for detergents and surfactants of detergents:

• limitations on the content of phosphorus and phosphorus compounds in consumer laundry and CADD;
• labelling requirements for detergents;
• specific biodegradability criteria that detergents and surfactants for detergents need to comply with;
• restrictions or bans on surfactants on grounds of biodegradability; and
• the information that manufacturers must hold at the disposal of designated public bodies and medical personnel (ingredient data sheet)

On 28 April 2023 the European Commission put forward a proposal for a revised Regulation on detergents and surfactants that would amend Regulation (EU) 2019/1020 and repeal Regulation (EC) No 648/2004. The new proposal introduces digital labelling and product passports for detergents and surfactants, new requirements for cleaners containing micro-organisms as well as rules for refilled detergents. This proposal updates the existing rules in line with the objectives of the European Green Deal, the Chemicals Strategy for Sustainability and the recently adopted Commission Communication on the long-term competitiveness of the EU.

The revised Regulation will ensure that the EU rules specific for detergents remain complementary to the general provisions applicable to chemicals i.e. the CLP Regulation and the REACH regulation. The revised Regulation puts forward the following changes:

Introduction of safety requirements for micro-organisms in detergents: New innovative cleaning products that use the action of micro-organisms have recently been developed. The revised Regulation will introduce safety requirements for micro-organisms in detergents. Furthermore, manufacturers must label the presence of micro-organisms in the detergents. This will allow these products to move freely in the Single Market and contribute to protecting human health and the environment since they may be alternatives to harmful chemicals.

Introduction of product passports: A product passport that contains compliance information will be introduced which will reduce the amount of non-compliant detergents and surfactants on the market in the EU. A detergent that is presented at customs can only be released for free circulation ad placed on the market if it has a corresponding product passport. National inspectors will continue to be responsible for carrying out checks on products, although a new IT system will screen all digital product passports at the external borders.

Introduction of voluntary digital labelling: For pre-packaged products some of the mandatory labelling information may be move to a digital label. For refillable products all labelling information may be provided digitally – except for dosage instructions for consumer laundry detergents.

Introduction of rules for refilled detergents: Under the revised Regulation refilled detergents are subject to the same rules as pre-packaged detergents. Furthermore, voluntary digital labelling is introduced for refilled detergents to further facilitate the use of these as this is sustainable and reduces packaging waste.

Simplification of market rules by abolishing unnecessary or redundant requirements: The following rules in the Detergent Regulation will be abolished:

• the obligation to provide an ingredient data sheet for hazardous detergents

• the obligatory involvement of approved laboratories performing tests

• the possibility to request a derogation for surfactants that do not meet the criteria of ultimate biodegradability

• the obligation for detergent and surfactant manufacturers to be established in the EU

Furthermore labelling requirements will be simplified and streamlined to reduce the administrative burden for the industry and making them easier to understand for end-users.