Biocidal Product Authorisation & Product Type (PT) Management
Biocidal products are subject to strict regulations to protect **public health, animal health, and the environment**. In Türkiye, the framework is set by the **Ministry of Health Biocidal Products Regulation**; in the EU, by the **Biocidal Products Regulation (BPR) (EU) 528/2012**. To market a biocidal product legally, a structured authorisation pathway is required—starting with the correct **Product Type (PT)** selection and supported by testing and a robust technical dossier. At Pier Compliance, we deliver an end-to-end model: **PT assessment → test strategy → technical dossier → label & SDS/GBF → submission and authority follow-up**. Our goal is to **reduce unnecessary testing costs, minimise revision/refusal risk, and accelerate market entry**.
Why Correct PT Selection Matters
Risks of selecting the wrong PT
An incorrect PT can lead to:
- irrelevant or excessive testing,
- claim–test inconsistency,
- label/SDS misalignment,
- delays, refusals, or repeated revisions,
- enforcement actions and product withdrawal risks.
Pier Compliance PT methodology
We evaluate PT using an integrated view of **formulation, intended use, target organisms, application area, user profile, and exposure scenario**—so dossier structure and testing are right from day one.
Scope: PT 1–22 (Strong focus on PT 1–19)
Pier Compliance supports **all PTs (PT 1–22)**, with extensive hands-on experience in the most common market segment **PT 1–19**.
PT 1–5: Disinfection & Hygiene (most common)
- **PT 1:** Human hygiene (hand/skin antiseptics, etc.)
- **PT 2:** Surface/area disinfection (institutional, domestic, etc.)
- **PT 3:** Veterinary hygiene
- **PT 4:** Food and feed area hygiene
- **PT 5:** Drinking water applications
PT 6–13: Preservatives (industrial)
- **PT 6–7:** In-can / film preservatives
- **PT 8–10:** Wood / fibre-leather-polymer / construction material preservatives
- **PT 11–13:** Liquid-system preservatives / slimicides / metalworking fluid preservatives
PT 14–19: Pest Control (public health sensitive)
- **PT 14:** Rodenticides
- **PT 15–17:** Avicides / molluscicides / piscicides
- **PT 18:** Insecticides, acaricides and other arthropod control
- **PT 19:** Repellents and attractants
PT 20–22: Special applications
- **PT 20:** Control of other vertebrates
- **PT 21:** Antifouling products
- **PT 22:** Embalming and taxidermist fluids
Testing Management & Accredited Lab Coordination
Claim substantiation
Claims such as "kills 99.9%" require the correct standards and study design. We manage **scope/standard selection**, sample planning, logistics, report tracking, and dossier integration.
Parallel timeline approach
While tests run, we build the dossier and label framework in parallel—so you gain speed without sacrificing compliance.
Compliant Labelling & SDS/GBF Preparation
The most audited area: the label
Labels are among the most penalised items during inspections. We align **classification, label elements, claim language, instructions for use, and risk mitigation measures**.
SDS/GBF consistency
We ensure **full consistency between the label and SDS/GBF**, avoiding contradictions that trigger revisions.
Submission & Authorisation Process Management
Türkiye (Ministry of Health) processes
We manage submission integrity checks, administrative/technical completeness, and authority Q&A response structuring.
EU BPR (528/2012) processes
We build a dossier strategy based on structured data logic and potential re-use across markets.
R4BP & IUCLID dossier management
Where applicable, we support **R4BP** and **IUCLID** data/dossier workflows.
Who Is This For?
Manufacturers, importers, brand owners/private label, retail & e-commerce channels, and industrial users.
Key Features
- Türkiye Ministry of Health authorisation support
- EU BPR (528/2012) consulting
- PT 1–PT 22 coverage
- Efficacy, stability and shelf-life test management
- R4BP & IUCLID dossier management
- Label + SDS/GBF fully aligned documentation
Key Features
- Türkiye Ministry of Health authorisation support
- EU BPR (528/2012) consulting
- PT 1–PT 22 coverage
- Efficacy, stability and shelf-life test management
- R4BP & IUCLID dossier management
- Label + SDS/GBF fully aligned documentation
Why Pier Compliance?
- Regulation-first dossier design, global accredited lab network, deep PT 1–22 experience, and a revision-minimising end-to-end approach.