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Global REACH Regulatory Compliance – An Overview

By meeting global REACH regulatory compliance, you will be able to sell and market your products in the European Union and EEA. It demonstrates that your substances are properly registered, evaluated, and managed in the market.

Basic global REACH compliance includes identification of the substances, assessment of the registration requirements, making the technical dossier, getting the chemicals tested by accredited agencies, and maintaining the safety sheets. In simple words, you need to comply with authorization, restriction, and supply chain communication mandates once you obtain the registration.

Enterslice helps companies reduce their risk of penalties, regulatory sanctions, and market interruptions. Get guidance on how you can increase consumer confidence, coordinate with existing registrants for sharing arrangements, and protect public health at the same time.

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Simplify your cross-border trade and get access to one of the best chemical markets in the world- let us help you remove every challenge, such as supply chain disruption, registration burden, SVHC tracking, and ongoing regulatory changes, with REACH compliance certificate assistance.

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Why does REACH Compliance Matter?

You cannot access the EU's chemical substance market without proper registration and compliance. It is only when you show your commitment to human health and the environment that you get the chance to conduct business in the vast consumer market. The importance of REACH compliance is as follows:

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Market Access

Once you get registration and authorization, you can enter the market and legally manufacture, import, and place your chemical substances on the EU and EEA market.

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Regulatory Compliance

Proper compliance will save you from penalties, administrative sanctions, customs barriers, and enforcement actions.

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Global Recognition

Regarded as one of the most influential chemical regulations in the world, you can easily access the international market with effective compliance.

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Risk Management

Identification of substantial hazardous materials can be done early, which could help you implement appropriate risk control measures.

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Competitive Edge

Businesses that maintain proper REACH compliance can demonstrate and position themselves as reliable suppliers in industries that require strict regulatory compliance.

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Enhanced Confidence in the Supply Chain

You can easily set up partnerships with distributors and importers in the EU/EEA and build credibility amongst the consumers, investors, and business partners.

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Helps Strengthen the Supply Chains

With proper authorizations and registration, you will have far fewer chances of supply chain disruptions, product withdrawals, and delays caused by improper paperwork, incorrect dossiers, or unclear customs clearances.

What Substances are Restricted Under REACH Compliance?

Certain substances and chemicals are restricted for manufacture, sale, or use in specific applications, or are subject to concentration limits under REACH compliance.

There are certain substances and chemicals that are restricted for manufacture, sale, or use for certain applications or limit the concentration in certain mixtures and substances under REACH compliance. Some of those restricted chemicals or compounds are:

  • Lead and related compounds
  • Cadmium and compounds
  • Mercury
  • Arsenic
  • Chromium VI
  • Nickel and compounds
  • Benzene
  • Toluene
  • Methanol
  • Some phthalates like BBP, DIBP, DBP, and DEHP
  • Polycyclic Aromatic Hydrocarbons (PAHs)
  • Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs)
  • Some Carcinogenic, Mutagenic, and Reprotoxic (CMR) substances
  • Trichloroethylene (TCE)
  • Dimethyl fumarate (DMF)
  • Creosote

Enterslice's Assistance for REACH Compliance

Take a look at how Enterslice will assist you in fulfilling your obligations towards REACH Compliance:

Eligibility Assessment

Help you check if REACH applies to your product, substance, article, or mixture or not through a full eligibility assessment. We identify registration, authorization, restriction, or notification obligations.

Identification of Substance

Before starting the process, we identify your substance and composition, review impurities, assess additives, and confirm whether the substance is already registered with ECHA to avoid duplication.

Strategize the Registration

We assist in calculating tonnage bands, identifying the applicable registration or authorization requirements, and tracking submission deadlines to ensure timely compliance.

Preparation of the Dossier

Prepare a complete technical dossier using IUCLID software, including toxicological, physicochemical, ecotoxicological information, product details, test reports, assessments, and study summaries.

Registration Submission

Our associates manage your filing through REACH-IT, ensuring complete technical documentation and coordinating with ECHA for any application-related queries.

Joint Submission and Data Sharing

If your substance is already registered, we assist with negotiations, Letters of Access, data-sharing agreements, and joint submissions to help you comply with REACH requirements.

Local and Only Representative Services

As a non-EU manufacturer or exporter, we provide support through an EU-based Only Representative to manage REACH obligations and maintain importer and customer records.

Chemical Safety Assessments

Support you in conducting hazard, exposure, and risk assessments across identified uses and prepare exposure scenarios required for certain REACH registrations.

Chemical Safety Reports

Help prepare and update Chemical Safety Reports demonstrating adequate risk control to support successful REACH registration.

Safety Data Sheet

Prepare and review REACH-compliant Safety Data Sheets (SDSs) and Extended SDSs while tracking regulatory updates to keep your documentation compliant.

SVHC Compliance

Review your proposed substances against the Candidate List, assess notification requirements, and communicate obligations for Substances of Very High Concern (SVHC).

Authorization

We determine whether your substance requires authorization and prepare and submit the necessary applications in accordance with EU regulations.

Restriction Compliance

Assess your substances against Annex XVII restrictions, review permitted uses, and verify concentration limits to ensure regulatory compliance.

GAP Analysis

Conduct a GAP assessment to identify potential compliance risks and recommend corrective actions and improvements for REACH compliance.

Updates for Your Dossier

Assist in updating your dossier whenever there are changes in tonnage, composition, uses, or hazard information to maintain ongoing REACH compliance.

Communication Handling

Provide expert assistance in managing all communications, dossier evaluations, compliance checks, and information requests from ECHA.

Supply Chain

Assist in maintaining supplier and customer documentation while verifying compliance across every stage of your supply chain.

Ongoing Advisory and Updates

Provide ongoing compliance training and regulatory update tracking so you remain informed about REACH amendments, ECHA updates, Candidate List alerts, and Annex XIV and XVII changes.

Frequency or Timeline for REACH Product Compliance

While most regulatory approvals have periodic renewals, REACH product compliance does not have a single or fixed validity period or even an annual renewal. Your compliance is ongoing, and the notification, authorization, and registration need to be updated as and when required.

Type Frequency
REACH Assessment Before starting the application to avoid errors
Registration of the Substance Before manufacturing or importing at least 1 tonne of the substance
Safety Data Sheet (SDS) Updates Whenever there is new hazard information or a change in regulations
Changes or Modifications to Your Dossier Whenever there are changes in composition, uses, classification, or company details
SVHC Candidate List Whenever the ECHA updates the Candidate List
Authorization Before the sunset date for the continued use of an authorized chemical
Restriction Compliance Before placing substances, mixtures, or articles on the EU/EEA market
SCIP Notifications for Articles Before placing an article on the EU market
Responses to ECHA Evaluations Before the deadlines specified by ECHA
Record Maintenance Retain records for at least 10 years after the last manufacture, import, supply, or use of the substance

What are the Penalties for Non-Conformity with REACH Regulatory Compliance?

You will face significant financial penalties, market restrictions, and legal issues for non-conformity with REACH regulatory compliance:

  • Monetary fines may be imposed by the national authorities.
  • Some serious issues may land you in criminal prosecution and imprisonment.
  • Your products and articles might be withdrawn from the market.
  • Businesses must recall their products, which may lead to significant financial difficulties.
  • You might be prohibited from manufacturing or importing in the EU or EEA.
  • Companies can no longer place their goods on the market.
  • Shipments may face detention, refusal of entry, or related enforcement actions.
  • Delays in product launches and disruption in the supply chain may occur due to non-registration.
  • You can lose your consumers and suffer reputational damage.

Avoid Heavy Fines with Our EU REACH Compliance Services

Get a 1:1 personalized consultation from an Enterslice expert for EU REACH compliance.

  • 30-min customized advisory call
  • EU-Based Consultants

What are the Challenges During REACH Compliance?

The challenges during REACH compliance are as follows:

Registration Obligations

Finding out the correct obligations that apply to your substance and registration, notification, authorization, or exemption under REACH can be a bit complex without professional assistance, which is why it's important for you to consider availing services.

Identification of the Substance

Correctly identifying your chemical substance and matching it against existing registrations is important because, if a registration already exists, you may face initial rejections due to a lack of data-sharing arrangements with existing registrants.

Collection of Data

Most businesses face delays due to inaccuracies in gathering the relevant physicochemical, toxicological, and ecotoxicological details that you will need for calculating the applicable tonnage band.

Letter of Access

Negotiating and reaching an arrangement with existing registrants can be time-consuming and costly if you do not have assistance from legal and chemical experts.

Technical Dossier

Compiling all the important documents like chemical test reports, safety data sheets, IUCLID dossier, the company's role, and other important paperwork often demands technical expertise.

High Costs for New Entrants

Compliance costs like professional fees, consulting costs, testing, and data access costs can be a bit too much for startups and SMEs.

Supply Chain Communications

You will have to coordinate with manufacturers, importers, only representatives, distributors, and downstream users to obtain and exchange the needed information- all of this can be a lot when you don't have an intermediary making things easier for you, so you can focus on core operations.

Meeting Deadlines

Things like dossier preparation, substance testing, and ECHA submission need to be completed within the agreed-upon or prescribed timeline; otherwise, you will face delays in market entry and product launch.

Need to Fulfil REACH Compliance Requirements?

Avoid late market placement of your substances and products by partnering with Enterslice.

  • Gap Analysis and Risk Management
  • Reduced Customs Barrier Risk

Why Trust Enterslice for EU REACH Compliance?

As a global regulatory compliance service provider, we have around 15+ years of experience in the chemical and substance registration industry. Key reasons to choose Enterslice for EU REACH Compliance are as follows:

  • Comprehensive Package: Dossier, Chemical Reports, GHS/CLP
  • Chemical Testing and Assessment Assistance via Local Experts
  • In-House Training for Management and Suppliers
  • One Dedicated Individual Manager for Each Client
  • Assistance for Tonnage and Supply Chain Management
  • Notification and Authorization: Continuous Monitoring
  • Substance Identification and Classification
  • Constant Support- Dossier Maintenance, SDS, SVHC, and More
  • Compliance For 12 Months- With Real-Time Tracking
  • 99% Client Retention Rate
  • No Hidden Charges- Transparent Costing
  • Get Local Assistance- 200+ Representatives in the EU
  • From Germany to Spain- We Cover Around 15+ Top Chemical States
  • Deep Expertise in EU Chemical and REACH Regulations

Frequently Asked Questions on REACH Compliance

Not exactly; you do not receive a REACH formal certification once you get approval. The compliance is instead demonstrated via your documentation, substance registration record, SDS files, SCIP notification, material declaration to consumers, and declaration of conformity.
Although some companies use the term "certificate of compliance", in practice you don't get a certificate from the ECHA.

You can check the substances on the publicly accessible databases as maintained by the ECHA for all major REACH registered lists. Businesses interested in registration and those who need compliance can check the SVHC candidate list, Annex XIV Authorization, and Annex XVII Restriction list- all through the ECHA website, which are updated regularly by the said regulator.
ECHA also provides an SCIP database for articles that contain SVHCs. Let us help you subscribe and get notifications on time and integrate list monitoring into your compliance workflows.

In simple words, compliance basically means that you meet every criterion for registration, evaluation, authorization, and restrictions of chemicals under the EC No. 1907/2006. The regulation's main objective is safe manufacture, import, and use of chemicals in the European Economic Area.

The registration applies to manufacturers, importers, distributors, and producers/importers of articles that meet the criteria under the EU regulations.

Well, the application is more nuanced in practice, while REACH does not directly apply to companies outside the EU, it will affect them if such legal entities want to export into the EU market. If you do want to export, then you will have to appoint a local "only representative" to obtain approval.

An only representative can be an individual or a legal entity who is either resident or established in the EU/EEA who can be appointed by a non-EU manufacturer or an exporter, article producer, or formulator that wants to sell, export, and manufacture in the EU via REACH registration obligations.

The details that are needed while you apply for the registration are the substance's identity, physicochemical properties, toxicological & ecotoxicological information, uses, exposure of the substance, classification, labelling, safety test reports, and chemical assessment/safety reports (when needed).

Well, generally polymers are exempt from registration, but some substances like monomers and related chemicals may still need to be registered in case they meet the requirements of REACH.

In case a chemical is already registered, then you, as a new applicant, will have to rely on that existing registration data through a data sharing arrangement under the REACH while also fulfilling your share of obligations.

You will get entangled with substantial fines, enforcement actions, restrictions on your products, customs barriers, full goods recall, and any other action as deemed fit by the concerned EU state.

A data sheet provides information on a substance or mixture's hazards, safe handling, transport, emergency measures, and disposal. So, when a company applies for REACH, they need to submit an SDS report under the EU and CLP regulations.

Your timeframe for the complete approval depends on various factors like the complexity of the substance, availability of the data, the number of times testing is needed, joint data arrangement, and dossier preparation. While simple applications can be done in three to six months, most complex cases take longer, such as 12 to 24 months.

Well, not always, but in certain cases it does. Sometimes, producers and importers of articles may have REACH compliance obligations in case their articles do contain substances that indeed get released during normal use or are of substances of very great concern.

A substance of very great concern is a list of chemicals that, as per ECHA, pose a serious hazard, such as carcinogenicity, reproductive toxicity, mutagenicity, persistence, and bioaccumulation. The SVHCs get added in the candidate list, and later they become open for authorizations.

Most businesses get confused thinking that once they get the approval, they are fully compliant with all the rules, but that is where they get it wrong. In practice, once you get the registration, you must keep the registration updated when new information becomes available to you, any regulatory information changes, or the volume changes. Post-registration compliance is most important throughout the supply chain and involves constant monitoring of regulatory development.

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