The Pharmaceutical Industry under the EU Green Deal refers to companies engaged in the research, development, manufacturing, and distribution of medicinal products within the European Union. This sector is specifically impacted by Regulation (EU) 2023/957 on the Corporate Sustainability Reporting Directive (CSRD), Regulation (EU) 2023/1434 on the European Sustainability Reporting Standards (ESRS), and the European Single-Use Plastics Regulation (ESPR) (EU) 2019/904. Unlike heavy industries, the pharmaceutical sector faces stringent obligations on sustainability reporting, supply chain due diligence, and packaging waste reduction rather than direct carbon border adjustments. Compliance requires detailed product-level environmental impact disclosures, supply chain traceability, and adherence to circular economy principles for packaging and plastic use.
EU Green Deal Compliance for the Pharmaceutical Industry
The EU Green Deal Compliance for the Pharmaceutical Industry is governed primarily by Regulation (EU) 2023/957 on the CSRD, which mandates comprehensive sustainability reporting for companies with over 250 employees or €40 million turnover, including pharmaceutical manufacturers. Additionally, the ESPR targets pharmaceutical packaging, requiring reduction and substitution of single-use plastics by 2025. The Corporate Sustainability Due Diligence Directive (CSDDD) (Proposal COM/2022/71) is expected to impose mandatory human rights and environmental due diligence on pharmaceutical supply chains by 2026. This guide details the specific compliance requirements, deadlines, and practical steps for pharmaceutical companies to avoid penalties of up to 5% of global turnover.
Key EU Green Deal Regulations Impacting Pharmaceuticals
The pharmaceutical sector is less exposed to the Carbon Border Adjustment Mechanism (CBAM) (Regulation (EU) 2023/956) as it primarily targets carbon-intensive imports like steel and cement. Instead, the pharmaceutical industry’s compliance focus is on:
- CSRD (Regulation (EU) 2023/957): Requires detailed sustainability disclosures including environmental, social, and governance (ESG) metrics from fiscal year 2025 onwards.
- ESPR (Regulation (EU) 2019/904): Enforces reduction of single-use plastics in packaging, with specific bans on certain plastic items by 3 July 2021 and extended obligations by 2025.
- CSDDD (Proposal COM/2022/71): Expected to require due diligence on environmental and human rights risks in supply chains, with enforcement starting 1 January 2026.
Product-Level Compliance Obligations
Pharmaceutical products are subject to specific sustainability and packaging requirements under the EU Green Deal framework. The following table summarizes key product categories and their compliance mandates:
| Product Category | Compliance Requirement | Applicable Regulation | Deadline | Penalty for Non-Compliance |
|---|---|---|---|---|
| Medicinal Products (oral, injectable) | ESG reporting on lifecycle emissions and supply chain impacts | CSRD (EU) 2023/957 | FY 2025 reporting (from 2026) | Up to 5% of global turnover |
| Plastic Packaging (blister packs, bottles) | Reduction and substitution of single-use plastics; mandatory recycling targets | ESPR (EU) 2019/904 | 3 July 2021 (initial bans), 2025 (extended obligations) | Fines up to €100,000 per violation (varies by Member State) |
| Active Pharmaceutical Ingredients (APIs) | Supply chain due diligence on environmental and human rights risks | CSDDD Proposal COM/2022/71 | 1 January 2026 (expected enforcement) | Up to 5% of global turnover |
| Medical Devices (pharma-related) | ESG reporting and packaging compliance | CSRD and ESPR | FY 2025 reporting; 2025 packaging compliance | Up to 5% turnover and fines |
Practical Compliance Steps for Pharmaceutical Companies
- Establish Sustainability Reporting Systems: Implement data collection and reporting processes aligned with ESRS standards to meet CSRD requirements by 2026.
- Audit Packaging Materials: Conduct a full audit of plastic packaging to identify single-use items targeted by ESPR and develop substitution plans before 2025.
- Supply Chain Due Diligence: Map suppliers of APIs and raw materials to assess environmental and human rights risks in preparation for CSDDD enforcement.
- Train Compliance Teams: Educate procurement, production, and legal teams on evolving EU Green Deal obligations and penalties.
- Engage with Certification Bodies: Obtain third-party verification of sustainability reports and packaging compliance to reduce enforcement risks.
Key Deadlines for the Pharmaceutical Industry
| Deadline | Requirement | Regulation | Impact |
|---|---|---|---|
| 3 July 2021 | Ban on certain single-use plastic items in packaging | ESPR (EU) 2019/904 | Immediate removal of banned plastics from pharma packaging |
| FY 2025 (reporting in 2026) | First mandatory sustainability reports under CSRD | CSRD (EU) 2023/957 | Full ESG disclosures including emissions, water use, and social factors |
| 1 January 2026 | Expected enforcement of mandatory supply chain due diligence | CSDDD Proposal COM/2022/71 | Obligation to identify and mitigate environmental and human rights risks |
| 2025 | Extended ESPR obligations on packaging recyclability and reduction | ESPR (EU) 2019/904 | Pharma packaging must meet circular economy criteria |
Truth Anchor: Under Regulation (EU) 2023/957, pharmaceutical companies with over 250 employees or €40 million turnover must submit their first sustainability reports for fiscal year 2025 by 31 March 2026, or face fines up to 5% of global turnover as stipulated in Article 30.
Internal Links for Further Compliance Guidance
Frequently Asked Questions - Pharmaceutical Industry EU Green Deal Compliance
1. Does the Carbon Border Adjustment Mechanism (CBAM) apply to pharmaceutical imports?
No. The CBAM (Regulation (EU) 2023/956) primarily targets carbon-intensive goods such as steel, cement, and aluminium. Pharmaceutical products are currently exempt due to their lower direct carbon emissions and different supply chain characteristics.
2. What are the main packaging requirements under the ESPR for pharmaceuticals?
The ESPR (EU) 2019/904 bans certain single-use plastic items in pharmaceutical packaging, such as plastic blister packs containing PVC/PVDC that cannot be recycled. By 2025, all pharma packaging must meet recyclability and reduction targets, including substitution with biodegradable or reusable materials where feasible.
3. Which pharmaceutical companies must comply with CSRD sustainability reporting?
All pharmaceutical companies operating in the EU with more than 250 employees or annual turnover exceeding €40 million must comply with the CSRD (Regulation (EU) 2023/957). This includes subsidiaries of multinational corporations if they meet these thresholds.
4. How should pharmaceutical companies prepare for the upcoming CSDDD enforcement?
Pharmaceutical companies should begin mapping their supply chains, particularly for APIs and raw materials, to identify environmental and human rights risks. Establishing due diligence policies, monitoring mechanisms, and remediation plans is essential before the expected enforcement date of 1 January 2026.
5. What penalties can pharmaceutical companies face for non-compliance?
Penalties vary by regulation but can be severe. Under CSRD and the proposed CSDDD, companies risk fines up to 5% of global annual turnover. For ESPR violations, Member States impose fines up to €100,000 per infraction, depending on national legislation.
Start Your Pharmaceutical EU Green Deal Compliance Assessment Now
Use our dedicated Pharmaceutical Compliance Assessment Tool to evaluate your company’s readiness for CSRD, ESPR, and CSDDD obligations. The tool guides you step-by-step through data collection, packaging audits, and supply chain due diligence. Upon completion, receive a tailored action plan with deadlines and risk mitigation strategies.
Clicking the link will open the assessment interface where you can upload your company data securely and receive instant compliance scoring.