European Unions (EU) Registration, Evaluation, Authorization (Restriction) of Chemicals (REACH) Regulation
REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
If the risks cannot be managed, authorities can restrict the use of substances in diﬀerent ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.
REACH will be governed by a nodal agency known as European Chemical Agency (ECHA). ECHA is the driving force among regulatory authorities in implementing the EU's ground-breaking chemicals legislation for the beneﬁt of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern. ECHA takes the overall responsibility for the REACH related activities .
REACH's eﬀect on companies:
REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.
In general, under REACH you may have one of these roles:
Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or ﬁnished products, like clothes, furniture or
Downstream users: Most companies use chemicals, sometimes even without realising it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.
Companies established outside the EU: If you are a company established outside the EU, you are not directly bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The primary responsibility for fulﬁlling the requirements of REACH, such as pre-registration or registration lies with the importers established in the European Union. But the non EU manufactures can comply with the regulation with the help of only representative established in the European Union.
A non-EU manufacturer may ﬁnd it more convenient/eﬃcient to get its substances pre-registered and registered in the EU through an only representative, in accordance with Article 8 of the REACH Regulation. An only representative is a natural or legal person established in the EU, appointed by a non-EU manufacturer by mutual agreement. As an only representative, this natural or legal person would fulﬁl the obligations of companies importing a substance on its own, in mixtures or in articles. It thereby alleviates the regulatory obligations resting on importers. Non-EU manufacturers may also want to choose this possibility if they consider that communication of information needed by the importers would require the disclosure of conﬁdential business information.
REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.
ECHA receives and evaluates each registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientiﬁc committees assess whether the risks of substances can be managed.
Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.
Registration Process :
To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. The main principle of REACH is “one substance, one registration”.
During joint submission process, one of the member among the manufacture of same chemicals nominate himself as lead registrant and the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co- registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in IUCLID6.
REACH TIMELINE :Post 31st May’2018, Deadline all chemicals are treated equally and chemicals which were not registered within REACH with European Chemical Agency will not be allowed to be marketed or manufactured within EU.
A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report.1. Technical Dossier
The total registration costs mainly consist of three parts:
Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is tonnage dependent. Data fee varies from substance to substance. It is ﬁxed by consortium or lead registrant. It is also tonnage based.
OR consultancy fees paid to OR to advise the whole registration process and prepare the individual part of registration dossier in IUCLID 6. The service fee covers SIEF/consortium communications, data gathering, IUCLID 6 dossier preparation and submission.
ECHA fees paid to European Chemical Agency. The fee is dependent on the annual tonnage of the substance and company size. Small and medium-sized enterprises (SME) enjoy discounts on ECHA fees (Euros).
Roles and responsibilities of REACH Only Representative :
In accordance with the Article 8 of REACH, the OR takes on the obligations of importers under REACH, in which case importers will be regarded as downstream users (thus do not need to register). Those obligations include:
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.
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:
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
Guidance on PCN requirements
Assess the portfolio to identify the
Trade names and Brand
Country specific variations
Use specific variations
Components specific variations
Possibility to group and optimize the Notifications
Generate the UFI core for the Mixture
Verify the UFI in cases of Mixture (external) in Mixtures
Inventory data to support classification & Labelling of Mixture
Guidance on Packaging – type, and size requirements
Update SDS to harmonized with Poison Centre Notified information
Revised and updated PCN Notification submission
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
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:
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 email@example.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)?
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:
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:
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:
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: